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NDC 67038-0200-40 BLISS BLOCK STAR - INVISIBLE DAILY SUNSCREEN 4.1; 11.5 g/100mL; g/100mL Details

BLISS BLOCK STAR - INVISIBLE DAILY SUNSCREEN 4.1; 11.5 g/100mL; g/100mL

BLISS BLOCK STAR - INVISIBLE DAILY SUNSCREEN is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by Bliss Products Holdings LLC. The primary component is TITANIUM DIOXIDE; ZINC OXIDE.

Product Information

NDC	67038-0200
Product ID	67038-200_d47460a1-476a-ee44-e053-2a95a90adecf
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	BLISS BLOCK STAR - INVISIBLE DAILY SUNSCREEN
Proprietary Name Suffix	SPF-30
Non-Proprietary Name	TITANIUM DIOXIDE, ZINC OXIDE
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	4.1; 11.5
Active Ingredient Units	g/100mL; g/100mL
Substance Name	TITANIUM DIOXIDE; ZINC OXIDE
Labeler Name	Bliss Products Holdings LLC
Pharmaceutical Class	Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2022-12-31

Package

Package Images

NDC 67038-0200-40 (67038020040)

Pricing Information	N/A
NDC Package Code	67038-200-40
Billing NDC	67038020040
Package	1 TUBE in 1 BOX (67038-200-40) / 40 mL in 1 TUBE
Marketing Start Date	2020-10-23
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 8927e2d2-b1e6-46f1-bede-f58658cbe7f2 Details

ACTIVE INGREDIENTS

Titanium Dioxide 4.1%

Zinc Oxide 11.5%

PURPOSE

Sunscreen

USES

Helps prevent sunburn
if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

WARNINGS

For external use only
Do not use on damaged or broken skin
When using this product keep out of eyes. Rinse with water to remove
Stop use and ask a doctor if rash occurs

SPL UNCLASSIFIED SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

DIRECTIONS

Apply liberally 15 minutes beforesun exposure
Reapply:
at least every 2 hours
use a water-resistant sunscreen if swimming orsweating

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
Limit time in the sun, especially from 10 a.m. – 2 p.m.
Wear long-sleeved shirts, pants, hats and sunglasses

INACTIVE INGREDIENTS

Water, Cyclopentasiloxane, Butylene Glycol, Glycerin, Dicaprylyl Carbonate, Propylene Glycol Dicaprylate, Disiloxane, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethicone, PEG-10 Dimethicone, Sodium Acrylates Crosspolymer-2, Polymethylsilsesquioxane, Butyloctyl Salicylate, Vinyl Dimethicone/ Methicone Silsesquioxane Crosspolymer, Vaccinium Angustifolium (Blueberry) Fruit Extract, Oenothera Biennis (Evening

Primrose) Flower Extract, Euterpe Oleracea Fruit Extract, Hibiscus Sabdariffa Flower Extract, Camellia Sinensis Leaf Extract, Pinus Palustris Leaf Extract, Ulmus Davidiana Root Extract, Pueraria Lobata Root Extract, Enantia Chlorantha Bark Extract, Lavandula Angustifolia (Lavender) Oil, Rosa Canina Fruit Oil, Anthemis Nobilis Flower Oil, Sodium Hyaluronate, Oleanolic Acid, Squalane, Glyceryl Caprylate, Aluminum Hydroxide, Polyglyceryl-6 Polyricinoleate, Sorbitan Caprylate, Stearic Acid, Synthetic Fluorphlogopite, Triethoxycaprylylsilane, Dipropylene Glycol, 1,2-Hexanediol, Dimethicone/PEG-10/15 Crosspolymer, Disteardimonium Hectorite, Magnesium Sulfate, Ethylhexylglycerin, Iron Oxides

OTHER INFORMATION

Protect this product from excessive heat and direct sun
May stain some fabrics

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BLISS BLOCK STAR - INVISIBLE DAILY SUNSCREEN SPF-30

titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:67038-200
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4.1 g in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	11.5 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
PROPYLENE GLYCOL DICAPRYLATE (UNII: 581437HWX2)
HEXAMETHYLDISILOXANE (UNII: D7M4659BPU)
MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
FERROUS OXIDE (UNII: G7036X8B5H)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
DIMETHICONE (UNII: 92RU3N3Y1O)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
BLUEBERRY (UNII: 253RUG1X1A)
OENOTHERA BIENNIS FLOWER (UNII: Y1YXJ1M6Z5)
EUTERPE OLERACEA WHOLE (UNII: Y57H6218HP)
HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
PINUS PALUSTRIS LEAF (UNII: OT6R5143A1)
ULMUS DAVIDIANA ROOT (UNII: URQ79U8261)
PUERARIA MONTANA VAR. LOBATA ROOT (UNII: PET93F4I3C)
ANNICKIA CHLORANTHA BARK (UNII: H70115MP4A)
LAVENDER OIL (UNII: ZBP1YXW0H8)
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
OLEANOLIC ACID (UNII: 6SMK8R7TGJ)
SQUALANE (UNII: GW89575KF9)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
SORBITAN MONOCAPRYLATE (UNII: 1VTA8DCP5Q)
STEARIC ACID (UNII: 4ELV7Z65AP)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:67038-200-40	1 in 1 BOX	10/23/2020
1		40 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	10/23/2020

Labeler - Bliss Products Holdings LLC (117126047)

Revised: 12/2021

Document Id: d47460a1-476a-ee44-e053-2a95a90adecf

Set id: 8927e2d2-b1e6-46f1-bede-f58658cbe7f2

Version: 7

Effective Time: 20211231