Label: PIPETTE MINERAL SUNSCREEN BROAD SPECTRUM SPF50- zinc oxide lotion
- NDC Code(s): 73517-382-01, 73517-382-02, 73517-382-03
- Packager: Amyris, 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 November 3, 2022
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- Active Ingredients
- Uses
- Warnings
- Do not use
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Directions
- Apply generously 15 minutes before sun exposure
- reapply at least every 2 hours
- Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularyly use a sunscreen with a Broad Spectrum value of SPF 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 shiirts, pants, hats and sunglasses
- 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, Caprylic/Capric Triglyceride, Glycerin, Squalane, Cetearyl Alcohol, Methyl Dihydroabietate, Sorbitan Olivate, Cetyl Palmitate, Coco-Glucoside, Ethyl Ferulate, Bisabolol, Hydroxyacetophenone, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Caprylyl/Capryl Glucosides, 1,2-Hexandiol, Caprylyl Glycol, Physalis Angulata Extract, Acacia Senegal Gum, Xanthan Gum, Sodium Gluconate.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PIPETTE MINERAL SUNSCREEN BROAD SPECTRUM SPF50
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73517-382 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 20 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) GLYCERIN (UNII: PDC6A3C0OX) SQUALANE (UNII: GW89575KF9) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F) SORBITAN OLIVATE (UNII: MDL271E3GR) CETYL PALMITATE (UNII: 5ZA2S6B08X) COCO GLUCOSIDE (UNII: ICS790225B) ETHYL FERULATE (UNII: 5B8915UELW) ISOSTEARIC ACID (UNII: X33R8U0062) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0) ACACIA SENEGAL WHOLE (UNII: QP4QYZ033C) XANTHAN GUM (UNII: TTV12P4NEE) SODIUM GLUCONATE (UNII: R6Q3791S76) BISABOLOL OXIDE A (UNII: 16AE65F94Y) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) HEXANEDIOL (UNII: ZIA319275I) CAPRYLYL GLYCOL (UNII: 00YIU5438U) PHYSALIS ANGULATA (UNII: W4TKW9D5GG) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73517-382-01 120 mL in 1 TUBE; Type 0: Not a Combination Product 06/01/2020 2 NDC:73517-382-02 30 mL in 1 TUBE; Type 0: Not a Combination Product 06/01/2020 3 NDC:73517-382-03 15 mL in 1 TUBE; Type 0: Not a Combination Product 06/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 06/01/2020 Labeler - Amyris, Inc (185930182)