SHEER PROTECTION SPF 30- zinc oxide cream 
Skin Script, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active Ingredient(s): Zinc Oxide (13.5%)

Purpose: Sunscreen

Uses:

Warnings:

Directions:

Inactive Ingredients: Aqua (Water), Caprylic/Capric Triglyceride, Candelilla/Jojoba/Rice Bran Polyglyceryl-3 Esters, Glycerin, Isodecyl Neopentanoate, Ethyl Macadamiate, Aleurites Moluccanus Seed Oil, Hydroxypropyl Starch Phosphate, Glyceryl Stearate, Hamamelis Virginiana (Witch Hazel) Water, Ergothioneine (L), Hordeum Distichon (Barley) Extract, Macadamia Ternifolia Seed Oil, Porphyra Umbilicalis (Red Algae) Extract, Santalum Album (Sandalwood) Extract, Phellodendron Amurense Bark Extract, Bisabolol (L-alpha), Glyceryl Isostearate, Sodium Stearoyl Lactylate, Polyglyceryl-10 Pentastearate, Polyhydroxystearic Acid, Tocopheryl Acetate (D-alpha), Tocopherol (D-alpha), Lecithin, Malic Acid (L), Lonicera Caprifolium (Honeysuckle) Flower Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Potassium Cetyl Phosphate, Hydrogenated Palm Glycerides, Alcohol, Cetearyl Alcohol, Behenyl Alcohol, Hydroxypropyl Methylcellulose, Sodium Lactate, Phytic Acid, Citric Acid, Sodium Hydroxide

Other Information:

PDP

SHEER PROTECTION SPF 30 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83657-610
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.0135 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
ETHYL MACADAMIATE (UNII: ANA2NCS6V1)  
PEG-60 GLYCERYL STEARATE (UNII: 85O35YN6YY)  
PORPHYRA UMBILICALIS (UNII: 14AN0J70WO)  
PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WITCH HAZEL (UNII: 101I4J0U34)  
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)  
ALCOHOL (UNII: 3K9958V90M)  
DOCOSANOL (UNII: 9G1OE216XY)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
SODIUM LACTATE (UNII: TU7HW0W0QT)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
LEVOMENOL (UNII: 24WE03BX2T)  
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)  
SANDALWOOD (UNII: 3641YW25N2)  
LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
WATER (UNII: 059QF0KO0R)  
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
BARLEY (UNII: 5PWM7YLI7R)  
HYDROXYPROPYL CORN STARCH (5% SUBSTITUTION BY WEIGHT) (UNII: 9M44R3409A)  
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)  
ALEURITES MOLUCCANA SEED (UNII: J87WJ3E7VW)  
POLYGLYCERYL-10 STEARATE (UNII: 90TF85HH91)  
MALIC ACID, L- (UNII: J3TZF807X5)  
MACADAMIA OIL (UNII: 515610SU8C)  
ERGOTHIONEINE (UNII: BDZ3DQM98W)  
FYTIC ACID (UNII: 7IGF0S7R8I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83657-610-0360 g in 1 TUBE; Type 0: Not a Combination Product01/01/2012
2NDC:83657-610-087.5 g in 1 JAR; Type 0: Not a Combination Product01/01/2012
3NDC:83657-610-637 g in 1 TUBE; Type 0: Not a Combination Product01/01/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02001/01/2012
Labeler - Skin Script, LLC (050951910)

Revised: 9/2023
Document Id: 04c86019-b54c-5bae-e063-6394a90a929f
Set id: 0450dcc9-3f8f-e2c2-e063-6294a90af60b
Version: 2
Effective Time: 20230907
 
Skin Script, LLC