Label: SPF 30 MINERAL SUNSCREEN- titanium dioxide, zinc oxide cream
- NDC Code(s): 53634-128-01
- Packager: Malin and Goetz 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 February 3, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
Directions
- Apply liberally and evenly 15 minutes before sun exposure
- Children under 6 months of age: ask a doctor
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 your time in the sun, especially from 10a.m. – 2 p.m.
- wear long-sleeved shirts, pants, hats, and sunglasses
- reapply after 40 minutes of swimming or sweating
- Immediately after towel drying
- At least every 2 hours
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INACTIVE INGREDIENT
Inactive ingredients
Water/Aqua/Eau, Glycerin, Caprylic/Capric Triglyceride, Butyrospermum Parkii (Shea) Butter, Niacinamide, Coconut Alkanes, Alumina, Glycogen, Isohexadecane, Polysorbate 60, Sorbitan Isostearate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Sodium Hyaluronate, Diethylhexyl Syringlidenemalonate, Triethoxycaprylylsilane, Ursolic Acid, Stearic Acid, Polyhydroxystearic Acid, hydrogenated Lecithin, Benzyl Alcohol, Phenoxyethanol, Tocopheryl Acetate, Coco-Caprylate/Caprate, Aminomethyl Propanol, Xanthan Gum, Citric Acid.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SPF 30 MINERAL SUNSCREEN
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53634-128 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 3.71 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 2.71 g in 100 mL Inactive Ingredients Ingredient Name Strength DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248) BENZYL ALCOHOL (UNII: LKG8494WBH) PHENOXYETHANOL (UNII: HIE492ZZ3T) SHEA BUTTER (UNII: K49155WL9Y) POLYSORBATE 60 (UNII: CAL22UVI4M) SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) URSOLIC ACID (UNII: P3M2575F3F) STEARIC ACID (UNII: 4ELV7Z65AP) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) GLYCERIN (UNII: PDC6A3C0OX) COCONUT ALKANES (UNII: 1E5KJY107T) XANTHAN GUM (UNII: TTV12P4NEE) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) ISOHEXADECANE (UNII: 918X1OUF1E) WATER (UNII: 059QF0KO0R) ALUMINUM OXIDE (UNII: LMI26O6933) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4) HYALURONATE SODIUM (UNII: YSE9PPT4TH) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) NIACINAMIDE (UNII: 25X51I8RD4) GLYCOGEN (UNII: 309GSC92U1) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53634-128-01 50 mL in 1 TUBE; Type 0: Not a Combination Product 12/15/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 12/15/2022 Labeler - Malin and Goetz Inc (138615930)
