Label: CC CREAM FAIR30- titanium dioxide, zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 81123-325-01 - Packager: The Creme Shop 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 May 17, 2021
If you are a consumer or patient please visit this version.
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- Active Ingredient
- Purpose
- Uses
- Warnings
- Warnings
- Warnings
- Warnings
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Directions
Apply liberally 15 minutes before sun exposure.
Reapply at least every 2 hours.
Use a 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 of 15 of 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.
Children under 6months of age: Ask a doctor. - Other Information
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Inactive Ingredient
Water, Sea Water, Dimethicone, Isododecane, Iron Oxide Yellow, Caprylic/Capric Triglyceride, Cetyl PEG/PPG-10/1 Dimethicone, Phenyl Trimethicone, Iron Oxide Red, Sodium Chloride, Butylene Glycol, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Iron Oxide Black, Phenoxyethanol, Sorbitan Isostearate, Triethoxycaprylylsilane, Ceresin, Silica, Magnesium Myristate, Magnesium Stearate, Sorbitan Sesquioleate, 1,2-Hexanediol, Synthetic Wax, Dimethicone/Vinyl Dimethicone Crosspolymer, Aluminum Hydroxide, Ethylhexylglycerin, Dehydroacetic Acid, Disteardimonium Hectorite, Methicone, Adenosine, Propylene Carbonate, Canola Oil, Garcinia Indica Seed Butter, Helianthus Annuus (Sunflower) Seed Oil, Lavandula Angustifolia (Lavender) Oil, Vitis vinifera (Grape) seed oil, Rose Centifolia Flower Extract, Citrus Aurantium Dulcis (Orange) Fruit Extract, Centella Asiatica Extract, Glycerin, Glycine Soja (Soybean) Seed Extract, Aloe Barbadensis Leaf Extract, Camellia Sinensis Leaf Extract, Cocos Nucifera (Coconut) Fruit Extract, Oryza Sativa (Rice) Extract, Prunus Persica (Peach) Fruit Extract, Fragaria Chiloensis (Strawberry) Fruit Extract, Sodium Hyaluronate
- Package Label
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INGREDIENTS AND APPEARANCE
CC CREAM FAIR30
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81123-325 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 5.5 mg in 100 mg ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 5.5 mg in 100 mg Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ISODODECANE (UNII: A8289P68Y2) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) PHENOXYETHANOL (UNII: HIE492ZZ3T) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) CERESIN (UNII: Q1LS2UJO3A) MAGNESIUM STEARATE (UNII: 70097M6I30) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) DEHYDROACETIC ACID (UNII: 2KAG279R6R) GRAPE SEED OIL (UNII: 930MLC8XGG) ROSA CENTIFOLIA FLOWER (UNII: CS4TE8FF7O) ORANGE (UNII: 5EVU04N5QU) SOYBEAN (UNII: L7HT8F1ZOD) BEACH STRAWBERRY (UNII: 98542F2TQS) FERROSOFERRIC OXIDE (UNII: XM0M87F357) SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) SUNFLOWER OIL (UNII: 3W1JG795YI) RICE GERM (UNII: 7N2B70SFEZ) PROPYLENE CARBONATE (UNII: 8D08K3S51E) GARCINIA INDICA SEED BUTTER (UNII: US2H3D7800) ALOE VERA LEAF (UNII: ZY81Z83H0X) PEACH (UNII: 3OKE88I3QG) SODIUM CHLORIDE (UNII: 451W47IQ8X) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) COCONUT (UNII: 3RT3536DHY) HYALURONATE SODIUM (UNII: YSE9PPT4TH) METHICONE (20 CST) (UNII: 6777U11MKT) FERRIC OXIDE RED (UNII: 1K09F3G675) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ADENOSINE (UNII: K72T3FS567) CANOLA OIL (UNII: 331KBJ17RK) LAVENDER OIL (UNII: ZBP1YXW0H8) CENTELLA ASIATICA (UNII: 7M867G6T1U) GLYCERIN (UNII: PDC6A3C0OX) GREEN TEA LEAF (UNII: W2ZU1RY8B0) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) DIMETHICONE (UNII: 92RU3N3Y1O) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM MYRISTATE (UNII: Z1917F0578) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81123-325-01 50 mg in 1 TUBE; Type 0: Not a Combination Product 12/11/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 12/11/2020 Labeler - The Creme Shop Inc (052907070) Registrant - The Creme Shop Inc (052907070) Establishment Name Address ID/FEI Business Operations Anneu Co., Ltd. 690377762 manufacture(81123-325)