Label: SUN PLUS SKINCARE SPF 30 MINERAL SUNSCREEN COCONUT PROBIOTIC- zinc oxide spray
- NDC Code(s): 61197-207-00
- Packager: Pacifica Beauty, LLC
- 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 January 24, 2023
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- Active ingredients Purpose
- Uses
- Uses
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Warnings
For external use only. Contents under pressure. Do not puncture or incinerate. Do not store at temperatures about 120ºF. For external use only. Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs. When using this product, keep out of eyes. Rinse with water to remove. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
- KEEP OUT OF REACH OF CHILDREN
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Directions
Shake well. Do not spray on face. If using onface, spray onto hands and rub on skin. Apply liberally 15 minutes before sun exposure. Reapply: After 80 minutes of swimming or sweating. Immediately after towel drying. At least every 2 hours. Children under 6 months: ask a doctor. 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-sleeve shirts, pants, hats and sunglasses.
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Inactive ingredients:
Bentonite, Bisabolol, Butyloctyl Salicylate, Caffeine, Caprylhydroxamic Acid, Caprylic/Capric Triglyceride, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Seed Oil, Cellulose Gum, Cetearyl Alcohol, Coco-Glucoside, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Jojoba Esters, Lactococcus Ferment Lysate, Methyl Dihydroabietate, Microcrystalline Cellulose, Parfum (natural), Polyhydroxystearic Acid, Tocopherol, Water.
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- Sun Plus Skincare SPF 30 Mineral Sunscreen Coconut Probiotic Label
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INGREDIENTS AND APPEARANCE
SUN PLUS SKINCARE SPF 30 MINERAL SUNSCREEN COCONUT PROBIOTIC
zinc oxide sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61197-207 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 14.5 g in 100 mL Inactive Ingredients Ingredient Name Strength HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W) METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SAFFLOWER OIL (UNII: 65UEH262IS) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) COCO GLUCOSIDE (UNII: ICS790225B) CAFFEINE (UNII: 3G6A5W338E) SUNFLOWER OIL (UNII: 3W1JG795YI) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) TOCOPHEROL (UNII: R0ZB2556P8) WATER (UNII: 059QF0KO0R) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) .ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) BENTONITE (UNII: A3N5ZCN45C) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61197-207-00 177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 01/24/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 01/24/2023 Labeler - Pacifica Beauty, LLC (868275517) Establishment Name Address ID/FEI Business Operations Bell International Laboratories, Incorporated 967781555 manufacture(61197-207)
