NDC | 70581-019-00 |
Set ID | 9dc66fbf-bc66-4c60-9675-05b193da91da |
Category | HUMAN OTC DRUG LABEL |
Packager | Laboratoires Biocosm SARL |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- Drug Facts
- Active ingredients
- Uses
- helps prevent sunburn
- if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
- Warnings
For external use only
Flammable until dry. Do not use near fire, flame or heat.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
- Directions
For sunscreen use:
- 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 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
- 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, phenoxyethanol, adenosine, magnesium sulfate, magnesium aspartate, ethylhexyl hydroxystearate, ethyl menthane carboxamide, silica, dimethiconol, dimethicone/vinyl dimethoicone crosspolymer, simmondsia chinensis (jojoba) seed oil, limonene, zinc gluconate, linalool, benzyl alcohol, copper gluconate, coriandrum sativum (coriander) fruit oil, moringa pterygosperma seed extract, passiflora edulis seed oil, disodium stearoyl glutamate, methicone, prunus armeniaca (apricot) kernel oil, aluminum starch octenylsuccinate, alumina, aluminum hydroxide; may contain: red 28 lake, red 7, iron oxides, bismuth oxychloride, titanium dioxide
Close - Package Labeling:
- INGREDIENTS AND APPEARANCE
10 ARMANI PRIMA CONTROL GLOW MOISTURIZER SBS SPF 35
octinoxate, titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70581-019 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 19 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) 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) LINALOOL, (+/-)- (UNII: D81QY6I88E) BENZYL ALCOHOL (UNII: LKG8494WBH) COPPER GLUCONATE (UNII: RV823G6G67) CORIANDER OIL (UNII: 7626GC95E5) MORINGA OLEIFERA SEED (UNII: TIX5482832) PASSIFLORA EDULIS SEED OIL (UNII: F3VOA31UHQ) DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M) 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:70581-019-00 1 in 1 BOX 01/01/2018 1 30 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 01/01/2018 Labeler - Laboratoires Biocosm SARL (288479491)