Label: PEOPLE4OCEAN SPF50 SUNSCREEN- zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 73192-030-00 - Packager: P4O Distribution Pty Ltd
- 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 July 1, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Uses
- Warnings
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Directions
- apply liberally and evenly 15 minutes before sun exposure
- Reapply:
- after 80 minutes of swimming or sweating
- immediately after towel drying
- 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, 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
- children under 6 months of age: Ask a doctor
- Other information
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Inactive ingredients
Purified water, Coco-Caprylate/Caprate, Caprilic/capric triglycerideº, Polyglyceryl-3 Polyricinoleate, Dimethicone, Octyl Palmitate, Isostearic Acidº, Butylene glycol, PEG-30 dipolyhydroxystearate, Beeswaxº, Glycerol, Polyethylene, Phenoxyethanol, Glyceryl oleate, Ethylhexylglycerin, Lavender Oil*, Ylang Ylang Flower Oil*, Patchouli Leaf Oil*, Vetiver Root Oil*, Geranium Oil*, Xanthan gum. ºOrganic | *Natural.
- Package Labeling:
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INGREDIENTS AND APPEARANCE
PEOPLE4OCEAN SPF50 SUNSCREEN
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73192-030 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 225 mg in 1 mL Inactive Ingredients Ingredient Name Strength PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO) YELLOW WAX (UNII: 2ZA36H0S2V) GLYCERIN (UNII: PDC6A3C0OX) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) PHENOXYETHANOL (UNII: HIE492ZZ3T) GLYCERYL OLEATE (UNII: 4PC054V79P) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) LAVENDER OIL (UNII: ZBP1YXW0H8) CANANGA OIL (UNII: 8YOY78GNNX) GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG) XANTHAN GUM (UNII: TTV12P4NEE) WATER (UNII: 059QF0KO0R) COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4) DIMETHICONE (UNII: 92RU3N3Y1O) ETHYLHEXYL PALMITATE (UNII: 2865993309) ISOSTEARIC ACID (UNII: X33R8U0062) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73192-030-00 1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 11/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 11/01/2019 Labeler - P4O Distribution Pty Ltd (745079594)
