Label: SUNSCREEN SPF 30- zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 72381-102-01 - Packager: Hamilton Therapeutics
- 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 30, 2022
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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
• For full protection, apply liberally 15 minutes before sun exposure.
• Reapply: • After 40 minutes of swimming or sweating • immediately after towel drying
• at least every 2 hours.
• For children under 6 months: Ask a doctor. • Sun Protection Measures: To decrease risk of exposure, regularly use a Broad Spectrum Sunscreen with an SPF of 15 or higher.
• Limit time in the sun, especially from 10AM-2PM.
• Wear long-sleeved shirts, pants, hats and sunglasses.
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INACTIVE INGREDIENT
Inactive ingredients Water, Caprylyl Caprylate/Caprate, Coconut Alkanes, Potassium Cetyl Phosphate, Cetearyl Alcohol, Glycerin, Bisabolol, Chamomilla Recutita (Matricaria) Flower Extract, Citrus Aurantium Amara (Bitter Orange) Flower Extract, Citrus Aurantium Dulcis (Orange) Peel Extract, Citrus Limon (Lemon) Peel Extract, Salvia Officinalis (Sage) Leaf Extract, Thymus Vulgaris (Thyme) Flower/Leaf Extract, Coco-Caprylate/Caprate, Glyceryl Stearate, Xanthan Gum, Polyhydroxystearic Acid, Glyceryl Distearate, Stearic Acid, Potassium Stearate, Octyldodecanol, Ethylhexyl Neopentanoate, Dimethicone, Phenethyl Alcohol, Sodium Dehydroacetate, Caprylhydroxamic Acid.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SUNSCREEN SPF 30
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72381-102 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 15 g in 100 mL Inactive Ingredients Ingredient Name Strength CITRUS AURANTIUM FLOWER (UNII: O730ZX2Z83) ORANGE PEEL (UNII: TI9T76XD44) LEMON PEEL (UNII: 72O054U628) SAGE (UNII: 065C5D077J) COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) XANTHAN GUM (UNII: TTV12P4NEE) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) POTASSIUM STEARATE (UNII: 17V812XK50) OCTYLDODECANOL (UNII: 461N1O614Y) DIMETHICONE (UNII: 92RU3N3Y1O) PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) CAPRYLYL CAPRYLATE/CAPRATE (UNII: 22MCG4RSMR) COCONUT ALKANES (UNII: 1E5KJY107T) GLYCERYL DISTEARATE (UNII: 73071MW2KM) WATER (UNII: 059QF0KO0R) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) LEVOMENOL (UNII: 24WE03BX2T) GLYCERIN (UNII: PDC6A3C0OX) CHAMOMILE (UNII: FGL3685T2X) THYME (UNII: CW657OBU4N) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) STEARIC ACID (UNII: 4ELV7Z65AP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72381-102-01 98 mL in 1 TUBE; Type 0: Not a Combination Product 06/15/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 06/15/2018 Labeler - Hamilton Therapeutics (099419360)
