Label: MINERAL SUNSCREEN SPF 30- zinc oxide lotion
- NDC Code(s): 81545-101-10, 81545-101-50
- Packager: Lee Indie & Co 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 January 10, 2023
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- ACTIVE INGREDIENT
- PURPOSE
- USES
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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DIRECTIONS
Shake before use.
- Apply generously to skin 15 minutes before sun exposure.
- During sun exposure, reapply: After 40 minutes of swimming or sweating
- Immediately after towel drying
- At least every two hours
Sun Protection Measures Spending time in the sun increases the risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with broad spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10a.m. to 4 p.m.; wear long sleeve shirts, pants, hats and sunglasses. Children under 6 months: ask a doctor
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INACTIVE INGREDIENTS
Water (aqua), Helianthus Annuus (Sunflower) Seed Oil, Caprylic/Capric Triglyceride, Squalane, Dicapryl Carbonate, Cetearyl Olivate, Sorbitan Olivate, Glycerin, Shea Butter Cetyl Esters, Sorbitan Sesquioleate, Polyhydroxystearic Acid, Diglycerin, Pinus Pinaster (Cluster Pine) Bark Extract, Punica Granatum (Pomegranate) Seed Oil, Phenethyl Alcohol, Pentylene Glycol, Propanediol, Aloe Barbadensis (Aloe Vera) Leaf Juice Powder, Panthenol, Xanthan Gum, Lauroyl Lysine
- OTHER INFORMATION
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MINERAL SUNSCREEN SPF 30
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81545-101 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 MARITIME PINE (UNII: 50JZ5Z98QY) POMEGRANATE SEED OIL (UNII: 0UI45XV0T6) ALOE VERA LEAF (UNII: ZY81Z83H0X) PANTHENOL (UNII: WV9CM0O67Z) XANTHAN GUM (UNII: TTV12P4NEE) PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) PENTYLENE GLYCOL (UNII: 50C1307PZG) PROPANEDIOL (UNII: 5965N8W85T) LAUROYL LYSINE (UNII: 113171Q70B) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) SORBITAN OLIVATE (UNII: MDL271E3GR) WATER (UNII: 059QF0KO0R) SUNFLOWER OIL (UNII: 3W1JG795YI) GLYCERIN (UNII: PDC6A3C0OX) SQUALANE (UNII: GW89575KF9) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) CETEARYL OLIVATE (UNII: 58B69Q84JO) DIGLYCERIN (UNII: 3YC120743U) SHEA BUTTER ETHYL ESTERS (UNII: V2CI786FPG) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81545-101-50 1 in 1 BOX 09/17/2021 1 NDC:81545-101-10 100 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 09/17/2021 Labeler - Lee Indie & Co Inc (117191089)
