Label: SUNSCREEN 100- titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 52554-1111-1, 52554-1111-2 - Packager: CMS LAB Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 October 19, 2017
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
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Warnings
Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
For external use only
Do not use when skin is red, inflamed, irritated, or painful
When using this product
- do not apply on other parts of the body
- do not use on damaged or broken skin
- avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water
- do not apply directly to wound or open cut
Stop use and ask a doctor if
- Rash or irritation on skin develops and lasts
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Directions
- Apply the adequate amount onto the entire face at the last stage of your skin care routine.
Re-apply frequently and generously to maintain protection. the palm of the hands and pat lightly with the fingertips.
- Apply liberally 15 minutes before sun exposure.
- Reapply at least every 2 hours.
- Use a water-resistant sunscreen if swimming or sweating.
- Children under 6 months of age: ask a doctor
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Inactive ingredients
WATER, DIBUTYL ADIPATE, POLYGLYCERYL-2 CAPRATE, SUCROSE STEARATE, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, STEARIC ACID, ALUMINA, GLYCERYL CAPRYLATE, SQUALANE, GLYCERIN, C12-15 ALKYL BENZOATE, PROPANEDIOL, 1,2-HEXANEDIOL, CENTELLA ASIATICA EXTRACT, HOUTTUYNIA CORDATA EXTRACT, PORTULACA OLERACEA EXTRACT, BUTYLOCTYL SALICYLATE, ARACHIDYL ALCOHOL, BEHENYL ALCOHOL, ARACHIDYL GLUCOSIDE, POLYSILICONE-15, DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE, ETHYLHEXYL TRIAZONE, CETEARYL ALCOHOL, SACCHARIDE HYDROLYSATE, SALVIA HISPANICA SEED EXTRACT, CURCUMA LONGA (TURMERIC) ROOT EXTRACT, GLYCERYL STEARATE, ECHIUM PLANTAGINEUM SEED OIL, CARDIOSPERMUM HALICACABUM FLOWER/LEAF/VINE EXTRACT, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL UNSAPONIFIABLES, TOCOPHEROL, PANTHENOL, SODIUM STEAROYL GLUTAMATE, POLYACRYLATE CROSSPOLYMER-6, t-BUTYL ALCOHOL, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, ROSE FLOWER OIL, JUNIPERUS MEXICANA OIL, XANTHAN GUM, ETHYLHEXYLGLYCERIN, HYDROGENATED LECITHIN, CERAMIDE 3 (CERAMIDE NP), SUCROSE STEARATE, CHOLESTEROL, PALMITIC ACID, CHOLESTERYL MACADAMIATE, SACCHARIDE ISOMERATE, HYDROLYZED LUPINE PROTEIN
- Sunscreen 100
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INGREDIENTS AND APPEARANCE
SUNSCREEN 100
titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52554-1111 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.26 g in 50 mL Inactive Ingredients Ingredient Name Strength JOJOBA OIL (UNII: 724GKU717M) STEARIC ACID (UNII: 4ELV7Z65AP) GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) SQUALANE (UNII: GW89575KF9) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) PROPANEDIOL (UNII: 5965N8W85T) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22) ALUMINUM OXIDE (UNII: LMI26O6933) GLYCERIN (UNII: PDC6A3C0OX) CENTELLA ASIATICA (UNII: 7M867G6T1U) ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) DOCOSANOL (UNII: 9G1OE216XY) PURSLANE (UNII: M6S840WXG5) POLYSILICONE-15 (UNII: F8DRP5BB29) DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20) ETHYLHEXYL TRIAZONE (UNII: XQN8R9SAK4) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) SACCHARIDE HYDROLYSATE (UNII: ED959S6ACY) CHIA SEED (UNII: NU0OLX06F8) TURMERIC (UNII: 856YO1Z64F) WATER (UNII: 059QF0KO0R) DIBUTYL ADIPATE (UNII: F4K100DXP3) SUCROSE STEARATE (UNII: 274KW0O50M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52554-1111-2 1 in 1 PACKAGE 10/19/2017 1 NDC:52554-1111-1 50 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 10/19/2017 Labeler - CMS LAB Inc. (557795012) Registrant - CMS LAB Inc. (557795012) Establishment Name Address ID/FEI Business Operations CMS LAB Inc. 557795012 relabel(52554-1111) Establishment Name Address ID/FEI Business Operations Kolmar Korea Co., Ltd. 689512611 manufacture(52554-1111)
