Label: SUN PLUS SKINCARE SPF 30 MINERAL FACE SHADE COCONUT PROBIOTIC- zinc oxide cream
- NDC Code(s): 61197-206-00
- 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 23, 2023
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- Active ingredients Purpose
- Uses
- Warnings
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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Directions
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 & early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher & other sun protection measures including: - limit time in the sun, especially from 10 a.m. - 2 p.m. - wear long-sleeve shirts, pants, hats & sunglasses.
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Inactive ingredients:
Aloe Barbadensis Leaf, Arachidyl Alcohol, Arachidyl Glucoside, Behenyl Alcohol, Bisabolol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea Butter), Caffeine, Caprylhydroxamic Acid, Capryloyl Glycerin/Sebacic Acid Copolymer, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Seed Oil, Cellulose Gum, Cetearyl Alcohol, Cetyl Alcohol, Citric Acid, Coco-Glucoside, Cocos Nucifera (Coconut) Oil, Diheptyl Succinate, Glycerin, Helianthus Annuus (Sunflower) Extract, Helianthus Annuus (Sunflower) Seed Oil, Heptyl Glucoside, Lactococcus Ferment Lysate, Methyl Dihydroabietate, Microcrystalline Cellulose, Oryza Sativa (Rice) Bran Extract, Parfum (Natural), Polyhydroxystearic Acid, Rosmarinus Officinalis (Rosemary) Leaf Extract, Sodium Gluconate, Sodium Hyaluronate, Sodium Stearoyl Glutamate, Theobroma Cacao (Cocoa) Seed Butter, Tocopherol, Water.
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- Sun Plus Skincare SPF 30 Mineral Face Shade Coconut Probiotic Label
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INGREDIENTS AND APPEARANCE
SUN PLUS SKINCARE SPF 30 MINERAL FACE SHADE COCONUT PROBIOTIC
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61197-206 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 16 g in 100 mg Inactive Ingredients Ingredient Name Strength DOCOSANOL (UNII: 9G1OE216XY) CAFFEINE (UNII: 3G6A5W338E) CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) COCONUT OIL (UNII: Q9L0O73W7L) TOCOPHEROL (UNII: R0ZB2556P8) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) SHEA BUTTER (UNII: K49155WL9Y) SAFFLOWER OIL (UNII: 65UEH262IS) GLYCERIN (UNII: PDC6A3C0OX) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SODIUM GLUCONATE (UNII: R6Q3791S76) RICE BRAN (UNII: R60QEP13IC) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) WATER (UNII: 059QF0KO0R) COCOA BUTTER (UNII: 512OYT1CRR) HEPTYL GLUCOSIDE (UNII: BU2OC48XBR) ALOE VERA LEAF (UNII: ZY81Z83H0X) ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ) METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F) HYALURONATE SODIUM (UNII: YSE9PPT4TH) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) ROSEMARY (UNII: IJ67X351P9) SUNFLOWER OIL (UNII: 3W1JG795YI) .ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) CETYL ALCOHOL (UNII: 936JST6JCN) COCO GLUCOSIDE (UNII: ICS790225B) DIHEPTYL SUCCINATE (UNII: 057N7SS26Y) HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61197-206-00 50 mg in 1 TUBE; Type 0: Not a Combination Product 01/23/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 01/23/2023 Labeler - Pacifica Beauty, LLC (868275517) Establishment Name Address ID/FEI Business Operations Bell International Laboratories, Incorporated 967781555 manufacture(61197-206)
