Label: TOP SECRET CC SPF 35- octinoxate, titanium dioxide cream
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- NDC Code(s): 70581-016-00
- Packager: BPS 60
- 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 December 30, 2019
If you are a consumer or patient please visit this version.
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- Drug Facts
- Active ingredients
- Use
- Warnings
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Directions
For sunscreen use:
- shake well before use
● apply generously 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 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-sleeved shirts, pants, hats, and sunglasses
● children under 6 months of age: Ask a doctor
- Other information
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Inactive ingredients
water, dimethicone, glycerin, alcohol denat., isododecane, PEG-10 dimethicone, dipropylene glycol, pentylene glycol, disteardimonium hectorite, betaine, talc, diisostearyl malate, fragrance, tocopheryl acetate, macadamia ternifolia seed oil, hydroxypropyl tetrahydropyrantriol, hydrolyzed prunus domestica, phenoxyethanol, adenosine, magnesium sulfate, magnesium aspartate, ethylhexyl hydroxystearate, ethyl menthane carboxamide, silica, dimethiconol, dimethicone/vinyl dimethicone crosspolymer, simmondsia chinensis (jojoba) seed oil, limonene, zinc gluconate, tin oxide, linalool, propylene glycol, copper gluconate, coriandrum sativum (coriander) fruit oil, moringa pterygosperma seed extract, carrageenan, passiflora edulis seed oil, disodium stearoyl glutamate, disodium phosphate, butylene glycol, BHT, citric acid, methicone, prunus armeniaca (apricot) kernel oil, aluminum starch octenylsuccinate, alumina, aluminum hydroxide; may contain: mica, red 28 lake, red 7, iron oxides, carmine, ferric ammonium ferrocyanide, bismuth oxychloride, titanium dioxide
- Package Labeling:
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INGREDIENTS AND APPEARANCE
TOP SECRET CC SPF 35
octinoxate, titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70581-016 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 50 mg in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 63 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) GLYCERIN (UNII: PDC6A3C0OX) ALCOHOL (UNII: 3K9958V90M) ISODODECANE (UNII: A8289P68Y2) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DIPROPYLENE GLYCOL (UNII: E107L85C40) PENTYLENE GLYCOL (UNII: 50C1307PZG) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) BETAINE (UNII: 3SCV180C9W) TALC (UNII: 7SEV7J4R1U) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) MACADAMIA OIL (UNII: 515610SU8C) HYDROXYPROPYL TETRAHYDROPYRANTRIOL (UNII: 4U3GMG1OT1) PHENOXYETHANOL (UNII: HIE492ZZ3T) ADENOSINE (UNII: K72T3FS567) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) MAGNESIUM ASPARTATE (UNII: R17X820ROL) ETHYLHEXYL HYDROXYSTEARATE (UNII: B7I80BVV5E) ETHYL MENTHANE CARBOXAMIDE (UNII: 6S7S02945H) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) JOJOBA OIL (UNII: 724GKU717M) LIMONENE, (+)- (UNII: GFD7C86Q1W) ZINC GLUCONATE (UNII: U6WSN5SQ1Z) STANNIC OXIDE (UNII: KM7N50LOS6) LINALOOL, (+/-)- (UNII: D81QY6I88E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) COPPER GLUCONATE (UNII: RV823G6G67) CORIANDER OIL (UNII: 7626GC95E5) MORINGA OLEIFERA SEED (UNII: TIX5482832) CARRAGEENAN (UNII: 5C69YCD2YJ) PASSIFLORA EDULIS SEED OIL (UNII: F3VOA31UHQ) DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) METHICONE (20 CST) (UNII: 6777U11MKT) APRICOT KERNEL OIL (UNII: 54JB35T06A) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) ALUMINUM OXIDE (UNII: LMI26O6933) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70581-016-00 1 in 1 BOX 12/26/2017 1 40 mL in 1 TUBE; 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 12/26/2017 Labeler - BPS 60 (272259304)
