Label: BENEFIT HELLO HAPPY AIR FOUNDATION SHADE 5- octinoxate, titanium dioxide stick
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Contains inactivated NDC Code(s)
NDC Code(s): 66472-073-01 - Packager: Benefit Cosmetics, LLC
- 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 January 6, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients
- Use
- 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.
- Children under 6 months of age: ask a doctor.
- Skin 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. till 2 p.m.
- Wear long-sleeved shirts, pants, hats & sunglasses.
- Other information
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Inactive ingredients
Hydrogenated Polyisobutene, Polyethylene, Synthetic Fluorphlogopite, Polymethyl Methacrylate, C12-15 Alkyl Ethylhexanoate, Butyrospermum Parkii (Shea) Butter, Cetyl Peg/ Ppg-10/1 Dimethicone, C20-40 Pareth-3, Caprylyl Glycol, Phenoxyethanol, Silica, Lauroyl Lysine, Bht, Tocopheryl Acetate, Fragrance (Parfum), Linalool, Ascorbyl Palmitate, Camellia Sinensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Ginkgo Biloba Leaf Extract, Lavandula Angustifolia (Lavender) Flower/ Leaf/Stem Extract, Tocopherol, Geraniol, Limonene, Pentaerythrityl Tetra-Di-T-Butyl Hydroxyhydrocinnamate, Citric Acid. [+/-: Bismuth Oxychloride (CI 77163), Iron Oxides (CI 77491, CI 77492, CI 77499), Titanium Dioxide (CI 77891)].
- Package Labeling:
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INGREDIENTS AND APPEARANCE
BENEFIT HELLO HAPPY AIR FOUNDATION SHADE 5
octinoxate, titanium dioxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66472-073 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 40 mg in 1 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 23.6 mg in 1 g Inactive Ingredients Ingredient Name Strength HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11) C12-15 ALKYL ETHYLHEXANOATE (UNII: GQJ580CH83) SHEA BUTTER (UNII: K49155WL9Y) C20-40 PARETH-3 (UNII: 68103A23TQ) CAPRYLYL GLYCOL (UNII: 00YIU5438U) PHENOXYETHANOL (UNII: HIE492ZZ3T) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) LAUROYL LYSINE (UNII: 113171Q70B) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) LINALOOL, (+/-)- (UNII: D81QY6I88E) ASCORBYL PALMITATE (UNII: QN83US2B0N) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CHAMOMILE (UNII: FGL3685T2X) GINKGO (UNII: 19FUJ2C58T) TOCOPHEROL (UNII: R0ZB2556P8) GERANIOL (UNII: L837108USY) LIMONENE, (+)- (UNII: GFD7C86Q1W) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) BISMUTH OXYCHLORIDE (UNII: 4ZR792I587) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66472-073-01 8.5 g in 1 TUBE; Type 0: Not a Combination Product 04/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 04/01/2020 Labeler - Benefit Cosmetics, LLC (070826813)
