Label: PREVENTION PLUS DAILY HYDRATING MOISTURIZER SPF 30- zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 62742-4183-1, 62742-4183-2, 62742-4183-3, 62742-4183-4 - 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 December 11, 2019
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
- WARNINGS AND PRECAUTIONS
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions For Sunscreen Use:
- Apply generously 15 minutes before sun exposure.
- Children under 6 months of age: ask a doctor.
- Reapply at least every 2 hours.
- Use a water resistant sunscreen if swimming or sweating.
- Immediatly after towel drying.
- at least every 2 hours.
- Sun protection measures.Spending time in the sun increase 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 a.m. - 2 p.m.
- wear long-sleeved shirts, pants, hats and sunglasses.
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INACTIVE INGREDIENT
Inactive ingredients: AQUA/WATER/EAU, CAPRYLIC/CAPRIC TRIGLYCERIDE, CYCLOPENTASILOXANE, GLYCERIN, BUTYLOCTYL SALICYLATE, DIMETHICONE, GLYCERYL STEARATE, PEG-100 STEARATE, BUTYROSPERMUM PARKII NUT EXTRACT, STYRENE/ACRYLATES COPOLYMER, LECITHIN, ISOSTEARIC ACID, POLYGLYCERYL-3 POLYRICINOLEATE, POLYHYDROXYSTEARIC ACID, CYCLOHEXASILOXANE, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, POLYSILICONE-31, SORBITAN STEARATE, CETYL ALCOHOL, PHENOXYETHANOL, HEA/SODIUM ACRYOLYDIMETHYLTAURATE/STEARETH-20 METHACRYLATE COPOLYMER, CITRUS AURANTIUM DULCIS (ORANGE) PEEL OIL, HYDROLYZED JOJOBA ESTERS, LIMONENE, CAPRYLYL GLYCOL, ALLANTOIN, C13-14 ISOPARAFFIN, LAMINARIA DIGITATA EXTRACT, ARTEMISIA VULGARIS EXTRACT, ETHYLHEXYLGLYCERIN, HEXYLENE GLYCOL, CITRUS NOBILIS (MANDARIN ORANGE) PEEL OIL, XANTHAN GUM, BISABOLOL, POLYSORBATE 80, TOCOPHERYL ACETATE, CAMELLIA SINENSIS LEAF EXTRACT, DECYL GLUCOSIDE, ERYTHRITOL, SODIUM HYALURONATE, BIOSACCHARIDE GUM-1, VANILLA PLANIFOLIA FRUIT EXTRACT, GLUCOSE, HYDROLYZED PEA PROTEIN, PYRUVIC ACID, SODIUM CHLORIDE, BAROSMA BETULINA LEAF OIL, TETRAHEXYLDECYL ASCORBATE, POTASSIUM SORBATE, SODIUM BENZOATE, HOMARINE HCL, SODIUM SUCCINATE, ARABIDOPSIS THALIANA EXTRACT, MICROCOCCUS LYSATE, PLANKTON EXTRACT, ERGOTHIONEINE.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PREVENTION PLUS DAILY HYDRATING MOISTURIZER SPF 30
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62742-4183 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 210 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) GLYCERIN (UNII: PDC6A3C0OX) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) DIMETHICONE (UNII: 92RU3N3Y1O) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) SHEANUT (UNII: 84H6HBP32L) STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) ISOSTEARIC ACID (UNII: X33R8U0062) POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) CYCLOMETHICONE 6 (UNII: XHK3U310BA) SUNFLOWER OIL (UNII: 3W1JG795YI) POLYSILICONE-15 (UNII: F8DRP5BB29) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) CETYL ALCOHOL (UNII: 936JST6JCN) PHENOXYETHANOL (UNII: HIE492ZZ3T) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4) STEARETH-20 METHACRYLATE (UNII: A268NZ57NB) CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T) HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W) LIMONENE, (+)- (UNII: GFD7C86Q1W) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ALLANTOIN (UNII: 344S277G0Z) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) LAMINARIA DIGITATA (UNII: 15E7C67EE8) ARTEMISIA VULGARIS WHOLE (UNII: JDR81QW9ZQ) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) HEXYLENE GLYCOL (UNII: KEH0A3F75J) MANDARIN OIL (UNII: NJO720F72R) XANTHAN GUM (UNII: TTV12P4NEE) LEVOMENOL (UNII: 24WE03BX2T) POLYSORBATE 80 (UNII: 6OZP39ZG8H) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) GREEN TEA LEAF (UNII: W2ZU1RY8B0) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) ERYTHRITOL (UNII: RA96B954X6) HYALURONATE SODIUM (UNII: YSE9PPT4TH) BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H) VANILLA (UNII: Q74T35078H) ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK) PEA PROTEIN (UNII: 7Q50F46595) PYRUVIC ACID (UNII: 8558G7RUTR) SODIUM CHLORIDE (UNII: 451W47IQ8X) AGATHOSMA BETULINA LEAF OIL (UNII: KOS935A04V) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM BENZOATE (UNII: OJ245FE5EU) HOMARINE HYDROCHLORIDE (UNII: 8866LNG61N) SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3) ARABIDOPSIS THALIANA (UNII: AI3L60HQ81) MICROCOCCUS LUTEUS (UNII: LV6L29Z6AX) ANACYSTIS NIDULANS (UNII: UV4FTL6UAW) ERGOTHIONEINE (UNII: BDZ3DQM98W) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62742-4183-1 170 g in 1 TUBE; Type 0: Not a Combination Product 12/11/2019 2 NDC:62742-4183-3 1 in 1 CARTON 12/11/2019 2 NDC:62742-4183-2 91 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:62742-4183-4 7 g in 1 TUBE; Type 0: Not a Combination Product 12/11/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 12/11/2019 Labeler - Allure Labs Inc (926831603)