NDC | 75936-205-01, 75936-205-02 |
Set ID | 98a9da1d-98ea-40a5-b99f-a60e54765d9f |
Category | HUMAN OTC DRUG LABEL |
Packager | Taylor James LTD |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
-
DOSAGE & ADMINISTRATION
Directions
Apply generously and evenly 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 broad spectrum SPF 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· Children under 6 months: Ask a doctor
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INACTIVE INGREDIENT
Inactive Ingredients Water, Isododecane, C2-15 Alkyl Benzoate, Iron Oxides, Glycerin, Propanediol, Cetyl Diglyceryl Tris(Trimethylsiloxy)silyethyl Dimethicone, Mica, Titanium Dioxide, 1,2-Hexanediol, Pyrus Malus (Apple) Fruit Extract, Sodium Chloride, Triethoxycaprylylsilane, Hydroxyacetophenone, Silica, Dimethicone/Vinyl Dimethicone Crosspolymer, Trisodium Ethylenediamine Disuccinate, Chlorphenesin, Tin oxide, Tocopherol, Chondrus Crispus Extract, Sodium Hyaluronate
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DAILY CORRECT CC CREAM BROAD SPECTRUM SPF 35 MEDIUM
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75936-205 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2 in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 20 in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) ISODODECANE (UNII: A8289P68Y2) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) GLYCERIN (UNII: PDC6A3C0OX) PROPANEDIOL (UNII: 5965N8W85T) MICA (UNII: V8A1AW0880) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) APPLE (UNII: B423VGH5S9) SODIUM CHLORIDE (UNII: 451W47IQ8X) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q) CHLORPHENESIN (UNII: I670DAL4SZ) STANNIC OXIDE (UNII: KM7N50LOS6) TOCOPHEROL (UNII: R0ZB2556P8) CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78) HYALURONATE SODIUM (UNII: YSE9PPT4TH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75936-205-02 1 in 1 BOX 05/11/2018 1 NDC:75936-205-01 47 mL in 1 PACKAGE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 05/11/2018 Labeler - Taylor James LTD (033381850) Establishment Name Address ID/FEI Business Operations Cosway Company, Inc. 052400223 manufacture(75936-205)