Label: CELESTY SENSITIVE SKIN SERIES SUNSCREEN SPF30- zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 81120-111-01 - Packager: MABA KOZMETIK LIMITED SIRKETI
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated December 14, 2020
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- Drug Facts:
- Active Ingredients
- Purpose
- Use
- Warnings
- Directions
- Other Information
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Inactive Ingredients
Water\Aqua\Eau, C12-15 Alkyl Benzoate, Glycerin, Butylene Glycol, Propanediol, Mirabilis Jalapa Flower/Leaf/Stem Extract, Niacinamide, Dimethicone, Panthenol (Pro Vitamin B5), PEG-100 Stearate, Polyethylene, Cetearyl Glucoside, Pentylene Glycol, Polyhydroxystearic acid, Phenoxyethanol, Squalane, Tocopheryl Acetate (Vitamin E), Cetyl Alcohol, Stearyl Alcohol, Cetearyl Alcohol, Behenyl Alcohol, Benzyl Alcohol, Butyrospermum Parkii (Shea Butter), Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Citric Acid, Caprylyl Glycol, Sodium Hyaluronate, Retinyl Palmitate (Vitamin A), Carbomer, Disodium EDTA, Hydroxyethylcellulose, Ethylhexylglycerin, Euterpe Oleracea Fruit Extract, Isostearic Acid, Vitis Vinifera (Grape) Seed Extract.
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SPL UNCLASSIFIED SECTION
soothe with SENSITIVE SKIN series
ZINC OXIDE
NIACINAMIDE
VITAMIN E
BEAUTY CARE
Brace Beauty, Embrace Purity.
www.celesty.com
Made in TURKEY
MABA KOZMETIK A.S.
ESENTEPE MAH. YUZBASI KAYA ALDOGAN SOK.
ONUR IS MERKEZI NO:12 D:8 ISTANBUL
Distributed by CELESTY LLC
3970 NW 167TH ST. MIAMI GARDENS,
FL 33054 - USA
info@celesty.com
(FOR SENSITIVE SKIN)
Protects sensitive skin against UVA rays and acts against free radical damage that may occur because of sun rays.
- Packaging
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INGREDIENTS AND APPEARANCE
CELESTY SENSITIVE SKIN SERIES SUNSCREEN SPF30
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81120-111 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 195 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) PROPANEDIOL (UNII: 5965N8W85T) MIRABILIS JALAPA FLOWERING TOP (UNII: 623IWX4U2M) NIACINAMIDE (UNII: 25X51I8RD4) DIMETHICONE (UNII: 92RU3N3Y1O) DEXPANTHENOL (UNII: 1O6C93RI7Z) PEG-100 STEARATE (UNII: YD01N1999R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) PENTYLENE GLYCOL (UNII: 50C1307PZG) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) PHENOXYETHANOL (UNII: HIE492ZZ3T) SQUALANE (UNII: GW89575KF9) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CETYL ALCOHOL (UNII: 936JST6JCN) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) DOCOSANOL (UNII: 9G1OE216XY) BENZYL ALCOHOL (UNII: LKG8494WBH) SHEA BUTTER (UNII: K49155WL9Y) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) CAPRYLYL GLYCOL (UNII: 00YIU5438U) HYALURONATE SODIUM (UNII: YSE9PPT4TH) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ACAI (UNII: 46AM2VJ0AW) ISOSTEARIC ACID (UNII: X33R8U0062) VITIS VINIFERA SEED (UNII: C34U15ICXA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81120-111-01 1 in 1 BOX 12/07/2020 1 60 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 12/07/2020 Labeler - MABA KOZMETIK LIMITED SIRKETI (503001418) Establishment Name Address ID/FEI Business Operations MABA KOZMETIK LIMITED SIRKETI 503001418 manufacture(81120-111)