Label: WELL PEOPLE BIO TINT SPF 30 SUNSCREEN 10W- zinc oxide cream
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- NDC Code(s): 76354-475-01
- Packager: e.l.f. Cosmetics, 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 April 27, 2023
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- Drug Facts
- Active ingredient
- Use
- Warning
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Directions
- Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours.
- Use water resistant sunscreen if swimming or sweating.
- 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 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
Water (Aqua), Coco-Caprylate/Caprate, Polyglyceryl-3 Polyricinoleate, Glycerin, Triethylhexanoin, Butyloctyl Salicylate, Butylene Glycol Dicaprylate/Dicaprate, Caprylic/Capric Triglyceride, Polyglyceryl-4 Isostearate, Magnesium Sulfate, Disteardimonium Hectorite, Shea Butter Ethyl Esters, Polyhydoxystearic Acid, Lecithin, Isostearic Acid, Gluconolactone, Cocos Nucifera (Coconut) Oil/Cocos Nucifera Oil*, Tocopherol, Helianthus Annuus (Sunflower) Seed Oil/ Helianthus Annuus Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil/ Simmondsia Chinensis Seed Oil*, Rubus Idaeus (Raspberry) Seed Oil/ Rubus Idaeus Seed Oil, Rosa Rubiginosa Seed Oil, Hippophase Rhamnoides (Sea Buckthorn) Oil/Hippophae Rhamnoides Oil, Crambe Abyssinica Seed Oil, Brassica Oleracea Italica (Broccoli) Seed Oil/ Brasica Oleracea Italica Oil, Aloe Barbadensis (Aloe) Leaf Juice/Aloe Barbadensis Leaf Juice, Maltodextrin, Potassium Sorbate, Glyceryl Caprylate, Sodium Benzoate, Isopropyl Titanium Triisostearate, Glyceryl Undecylenate, Calcium Gluconate, Phytic Acid MAY CONTAIN: Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499) *Organic Ingredients
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INGREDIENTS AND APPEARANCE
WELL PEOPLE BIO TINT SPF 30 SUNSCREEN 10W
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76354-475 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 200 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H) POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4) GLYCERIN (UNII: PDC6A3C0OX) TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) SHEA BUTTER ETHYL ESTERS (UNII: V2CI786FPG) ISOSTEARIC ACID (UNII: X33R8U0062) GLUCONOLACTONE (UNII: WQ29KQ9POT) COCONUT OIL (UNII: Q9L0O73W7L) TOCOPHEROL (UNII: R0ZB2556P8) SUNFLOWER OIL (UNII: 3W1JG795YI) JOJOBA OIL (UNII: 724GKU717M) RASPBERRY SEED OIL (UNII: 9S8867952A) ROSA RUBIGINOSA SEED OIL (UNII: 8M1P49MWAP) CRAMBE HISPANICA SUBSP. ABYSSINICA SEED OIL (UNII: 0QW9S92J3K) BROCCOLI SEED OIL (UNII: SY01LVD4G4) ALOE VERA LEAF (UNII: ZY81Z83H0X) MALTODEXTRIN (UNII: 7CVR7L4A2D) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) SODIUM BENZOATE (UNII: OJ245FE5EU) ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I) GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544) CALCIUM GLUCONATE (UNII: SQE6VB453K) FYTIC ACID (UNII: 7IGF0S7R8I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76354-475-01 1 in 1 BOX 09/01/2021 1 35.5 mL in 1 BOTTLE; 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 09/01/2021 Labeler - e.l.f. Cosmetics, Inc (093902816) Establishment Name Address ID/FEI Business Operations Zhejiang Ayan Biotech Co.,Ltd. 544377996 manufacture(76354-475)
