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NDC 76049-0202-30 Stay All Day 10-in-1 Illuminating Skin Veil Broad-Spectrum SPF 30 Sunscreen Water-Resistant 80 minutes KITTEN 50; 186 mg/mL; mg/mL Details

Stay All Day 10-in-1 Illuminating Skin Veil Broad-Spectrum SPF 30 Sunscreen Water-Resistant 80 minutes KITTEN 50; 186 mg/mL; mg/mL

Stay All Day 10-in-1 Illuminating Skin Veil Broad-Spectrum SPF 30 Sunscreen Water-Resistant 80 minutes KITTEN is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Stila Style, LLC. The primary component is OCTINOXATE; ZINC OXIDE.

Product Information

NDC	76049-0202
Product ID	76049-202_dc620d3f-8812-df05-e053-2995a90a8409
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	Stay All Day 10-in-1 Illuminating Skin Veil Broad-Spectrum SPF 30 Sunscreen Water-Resistant 80 minutes KITTEN
Proprietary Name Suffix	n/a
Non-Proprietary Name	OCTINOXATE, ZINC OXIDE
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	50; 186
Active Ingredient Units	mg/mL; mg/mL
Substance Name	OCTINOXATE; ZINC OXIDE
Labeler Name	Stila Style, 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	2023-12-31

Package

Package Images

NDC 76049-0202-30 (76049020230)

Pricing Information	N/A
NDC Package Code	76049-202-30
Billing NDC	76049020230
Package	1 TUBE in 1 CARTON (76049-202-30) / 30 mL in 1 TUBE
Marketing Start Date	2021-06-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL dc620d3f-8811-df05-e053-2995a90a8409 Details

Drug Facts

Active Ingredients

Octinoxate 5.0%

Zinc Oxide 18.6%

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.

Stop use and ask a doctor

if rash occurs.

When using this product

keep out of eyes. Rinse with water to remove.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply liberally 15 minutes before sun exposure and as needed

• reapply at least every 2 hours

• reapply after 80 minutes of swimming or sweating

• reapply after towel drying

• children under 6 months: Ask a doctor

• 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 of 15 or higher and other sun protection measures including:

• limit time in the sun especially from 10am - 2pm

• wear long-sleeved shirts, pants, hats, and sunglasses

Other Information

Protect the product in this container from excessive heat and direct sun.

Inactive ingredients :

WATER/AQUA/EAU, C12-15 ALKYL BENZOATE, HYDROXYPROPYLCOCOATE PEG-8 DIMETHICONE, DIMETHICONE CROSSPOLYMER,-

CYCLOPENTASILOXANE, GLYCERIN, ISOPENTYLDIOL, PYRUS MALUS (APPLE) FRUIT EXTRACT, ISODODECANE, DIMETHICONE, MICA, TRIETHOXYCAPRYLYLSILANE, PHENOXYETHANOL, SODIUM CHLORIDE, CAPRYLIC/CAPRIC TRIGLYCERIDE, PHYSALIS ANGULATA EXTRACT, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, DISTEARDIMONIUM HECTORITE, POLYHYDROXYSTEARIC ACID, SILICA, PEG/PPG-18/18 DIMETHICONE, CAPRYLYL GLYCOL, ETHYLHEXYLGLYCERIN, HEXYLENE GLYCOL, PROPYLENE CARBONATE, PARFUM, PHYTIC ACID, SODIUM HYDROXIDE, ROSMA R INUS OFFICINALIS (ROSEMARY) LEAF EXTRACT, PALMITOYL TRIPEPTIDE-37, DECARBOXY CARNOSINE HCL, TOCOPHEROL, BUTYLENE GLYCOL, LINALOOL, HEXYL CINNAMAL. (+/-) IRON OXIDES (CI 77491, CI 77492, CI 77499), TITANIUM DIOXIDE (CI 77891). <ILN C121042.2>

Package Labeling:

INGREDIENTS AND APPEARANCE

STAY ALL DAY 10-IN-1 ILLUMINATING SKIN VEIL BROAD-SPECTRUM SPF 30 SUNSCREEN WATER-RESISTANT 80 MINUTES KITTEN

octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76049-202
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	50 mg in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	186 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
HYDROXYPROPYLCOCOATE PEG-8 DIMETHICONE (UNII: 8TE0BZU36S)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPENTYLDIOL (UNII: 19NOL5474Q)
APPLE (UNII: B423VGH5S9)
ISODODECANE (UNII: A8289P68Y2)
DIMETHICONE (UNII: 92RU3N3Y1O)
MICA (UNII: V8A1AW0880)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PHYSALIS ANGULATA WHOLE (UNII: W4TKW9D5GG)
SUNFLOWER OIL (UNII: 3W1JG795YI)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
FYTIC ACID (UNII: 7IGF0S7R8I)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ROSEMARY (UNII: IJ67X351P9)
DECARBOXY CARNOSINE HYDROCHLORIDE (UNII: 6X7K9I5QR7)
TOCOPHEROL (UNII: R0ZB2556P8)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
CINNAMALDEHYDE (UNII: SR60A3XG0F)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:76049-202-30	1 in 1 CARTON	06/01/2021
1		30 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	06/01/2021

Labeler - Stila Style, LLC (809192896)

Revised: 4/2022

Document Id: dc620d3f-8812-df05-e053-2995a90a8409

Set id: dc620d3f-8811-df05-e053-2995a90a8409

Version: 1

Effective Time: 20220411