Label: SPF 30 MINERAL SUNSCREEN FACE NECK- zinc oxide cream
-
Contains inactivated NDC Code(s)
NDC Code(s): 62742-4086-1, 62742-4086-2, 62742-4086-3 - Packager: Allure Labs Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 July 11, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
-
INDICATIONS & USAGE
Uses:
- High protection against sunburn.
- Higher SPF gives more sunburn protection.
- 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 10am - 2pm.
- Wear long sleeved shirts, pants, hats and sunglasses.
- WARNINGS
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- STORAGE AND HANDLING
-
INACTIVE INGREDIENT
Water (Aqua), Cyclopentasiloxane, Butylene Glycol, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Cyclohexasiloxane, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Sorbitan Stearate, Dimethicone, Cetyl Alcohol, Caprylic/Capric Triglyceride, Organic Butyrospermum Parkii (Shea) Butter, Polyacrylamide, C13-14 Isoparaffin, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Sodium Hyaluronate, Dipotassium Glycyrrhizate, Tocopheryl Linoleate/Oleate, Physalis Angulata Extract, Teprenone, Leontopodium Alpinum Meristem Cell Culture, Polygonum Aviculare Extract, Imperata Cylindrica Root Extract, Arabidopsis Thaliana Extract, Plankton Extract, Micrococcus Lysate, Organic Camellia Sinensis Leaf Extract, Phoenix Dactylifera (Date) Fruit Extract, Sidium Lactete, Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-7, Organic Aloe Barbadensis Leaf Juice, Lecithin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polysorbate-20, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Laureth-7, Xanthan Gum, Carbomer, PEG-8, Tocopherol, Ascorbyl Palmitate, Ascorbic Acid, Citric Acid, Disodium EDTA.
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
SPF 30 MINERAL SUNSCREEN FACE NECK
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62742-4086 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 186 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) CYCLOMETHICONE 6 (UNII: XHK3U310BA) POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) DIMETHICONE (UNII: 92RU3N3Y1O) CETYL ALCOHOL (UNII: 936JST6JCN) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) SHEA BUTTER (UNII: K49155WL9Y) POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) HYALURONATE SODIUM (UNII: YSE9PPT4TH) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) PHYSALIS ANGULATA (UNII: W4TKW9D5GG) TEPRENONE (UNII: S8S8451A4O) LEONTOPODIUM ALPINUM FLOWERING TOP (UNII: QQC1AK06RK) POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF) IMPERATA CYLINDRICA ROOT (UNII: VYT2JA85NH) ARABIDOPSIS THALIANA (UNII: AI3L60HQ81) CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17) PHOENIX RECLINATA FRUIT (UNII: B140O227ZE) SODIUM LACTATE (UNII: TU7HW0W0QT) PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M) PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R) ALOE VERA LEAF (UNII: ZY81Z83H0X) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L) POLYSORBATE 20 (UNII: 7T1F30V5YH) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) HEXYLENE GLYCOL (UNII: KEH0A3F75J) LAURETH-7 (UNII: Z95S6G8201) XANTHAN GUM (UNII: TTV12P4NEE) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) TOCOPHEROL (UNII: R0ZB2556P8) ASCORBYL PALMITATE (UNII: QN83US2B0N) ASCORBIC ACID (UNII: PQ6CK8PD0R) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) EDETATE DISODIUM (UNII: 7FLD91C86K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62742-4086-1 2 mL in 1 TUBE; Type 0: Not a Combination Product 07/14/2016 2 NDC:62742-4086-3 1 in 1 CARTON 07/14/2016 2 NDC:62742-4086-2 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 final part352 07/11/2016 Labeler - Allure Labs Inc (926831603) Establishment Name Address ID/FEI Business Operations Allure Labs Inc 926831603 manufacture(62742-4086)