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NDC 81535-0211-01 Face and Body Mineral SPF Non-Tinted 30; 100 mg/g; mg/g Details

Face and Body Mineral SPF Non-Tinted 30; 100 mg/g; mg/g

Face and Body Mineral SPF Non-Tinted is a TOPICAL AEROSOL, FOAM in the HUMAN OTC DRUG category. It is labeled and distributed by Flawless Skin Care, LLC (dba Abby Skin Clinic). The primary component is TITANIUM DIOXIDE; ZINC OXIDE.

Product Information

NDC	81535-0211
Product ID	81535-211_be28ca4c-97a8-4e3d-9c94-e2199ec95db4
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	Face and Body Mineral SPF Non-Tinted
Proprietary Name Suffix	n/a
Non-Proprietary Name	Titanium Dioxide, Zinc Oxide
Product Type	HUMAN OTC DRUG
Dosage Form	AEROSOL, FOAM
Route	TOPICAL
Active Ingredient Strength	30; 100
Active Ingredient Units	mg/g; mg/g
Substance Name	TITANIUM DIOXIDE; ZINC OXIDE
Labeler Name	Flawless Skin Care, LLC (dba Abby Skin Clinic)
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2024-12-31

Package

Package Images

NDC 81535-0211-01 (81535021101)

Pricing Information	N/A
NDC Package Code	81535-211-01
Billing NDC	81535021101
Package	100 g in 1 CAN (81535-211-01)
Marketing Start Date	2021-03-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL f4a34add-2791-43a0-8bf9-e96b5c75f167 Details

ACTIVE INGREDIENTS:

Titanium Dioxide 3%

Zinc Oxide 10%

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

DIRECTIONS:

Shake well before using.
Push nozzle up to release safety tab.
Apply liberally 15 minutes before sun exposure.
Reapply:
- After 40 minutes of swimming or sweating
- Immediately after towel drying
- At least every 2 hours
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 value of 15 or higher and other sun protection measures including:
- Limit time in the sun, especially from 10 am-2 pm
- Wear long-sleeved shirts, pants, hats, and sunglasses

INACTIVE INGREDIENTS:

Butyloctyl Salicylate, Cl2-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cellulose Gum, Ceteareth 20, Cetearyl Alcohol, Citric Acid, Disodium EDTA, Glycereth-26, Glycerin, Glyceryl Stearate, Methyl Methacrylate Crosspolymer, Microcrystalline Cellulose, Octyldodecyl Neopentanoate, Polymethyl Methacrylate, Polysorbate 80, Polyurethane-2, Trans-1,3,3,3-Tetrafluoropropene, Tricontanyl PVP, Triethoxycaprylylsilane, Trimethoxycaprylylsilane, Water

OTHER INFORMATION:

Protect this product from excessive heat and direct sun
May stain some fabrics
Store between 68° to 104° F (20° to 40° C).
Do not store at temperatures above 120° F.

Principal Display Panel - 100 g Can Label

ABBY SKIN CARE

ABBY ODIAMAR PACLIBAR

FACE & BODY

MINERAL SPF

NON-TINTED

Oil Free Mousse Sunscreen

broad spectrum SPF 30

water resistant (40 mins)

Great for all skin types
Photo-stable will not degrade in sunlight
FREE of chemical sunscreen filters, dyes,

fragrances, oils and preservatives
Reef friendly
non-comedogenic

3.5 oz | 100 g

Principal Display Panel - 100 g Can Label

INGREDIENTS AND APPEARANCE

FACE AND BODY MINERAL SPF NON-TINTED

titanium dioxide, zinc oxide aerosol, foam

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:81535-211
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	30 mg in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	100 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
GLYCERETH-26 (UNII: NNE56F2N14)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
1,3,3,3-TETRAFLUOROPROPENE, (1E)- (UNII: 5I2481UOO8)
TRICONTANYL POVIDONE (UNII: N0SS3Q238D)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:81535-211-01	100 g in 1 CAN; Type 0: Not a Combination Product	03/01/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	04/24/2018

Labeler - Flawless Skin Care, LLC (dba Abby Skin Clinic) (031934930)

Name	Address	ID/FEI	Business Operations
Establishment
Custom Analytics LLC		144949372	ANALYSIS(81535-211)

Name	Address	ID/FEI	Business Operations
Establishment
Fragrance Manufacturing Inc. (FMI)		793406000	MANUFACTURE(81535-211)

Name	Address	ID/FEI	Business Operations
Establishment
Keystone Industries		014769301	PACK(81535-211)

Revised: 3/2021

Document Id: be28ca4c-97a8-4e3d-9c94-e2199ec95db4

Set id: f4a34add-2791-43a0-8bf9-e96b5c75f167

Version: 1

Effective Time: 20210323