Label: FIRST AID BEAUTY FAB WEIGHTLESS MINERAL SUNSCREEN BROAD SPECTRUM SPF 30- zinc oxide liquid
- NDC Code(s): 69423-690-44
- Packager: The Procter & Gamble Manufacturing Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 July 27, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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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
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Directions
- shake well before use
- apply liberally 15 minutes before sun exposure
- reapply at least every 2 hours
- use water resistant sunscreen if swimming or sweating
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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 sun, especially from 10 a.m. - 2 p.m.
- wear long-sleeved shirts, pants, hats, and sunglasses
- children under 6 months: ask a doctor
- Other information
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Inactive ingredients
Ethylhexyl Olivate, Isododecane, Coconut Alkanes, Aluminum Starch Octenylsuccinate, Caprylic/Capric Triglyceride, Water (Aqua), Butylene Glycol, Polyglyceryl-6 Polyricinoleate, Jojoba Esters, Cellulose, Stearalkonium Hectorite, Sodium Chloride, Squalane, Polyglyceryl-3 Polyricinoleate, Polyglyceryl-3 Diisostearate, Phenoxyethanol, Tocopheryl Acetate, Coco-Caprylate/Caprate, Trihydroxystearin, Caprylyl Glycol, Polyhydroxystearic Acid, Trisodium Ethylenediamine Disuccinate, Glycerin, Glycyrrhiza Glabra (Licorice) Root Extract, Propanediol, Sorbic Acid, Silica, Camellia Sinensis Leaf Extract, Chrysanthemum Parthenium (Feverfew) Extract, Alumina, Tocopherol, Mica (CI 77019), Iron Oxides (CI 77492), Iron Oxides (CI 77491), Iron Oxides (CI 77499), Titanium Dioxide (CI 77891)
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- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FIRST AID BEAUTY FAB WEIGHTLESS MINERAL SUNSCREEN BROAD SPECTRUM SPF 30
zinc oxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69423-690 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 22 g in 100 mL Inactive Ingredients Ingredient Name Strength POWDERED CELLULOSE (UNII: SMD1X3XO9M) TANACETUM PARTHENIUM WHOLE (UNII: 6GE7Z0761K) POLYGLYCERYL-10 POLYRICINOLEATE (UNII: DHM1T5XO11) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) GREEN TEA LEAF (UNII: W2ZU1RY8B0) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) ALUMINUM OXIDE (UNII: LMI26O6933) MICA (UNII: V8A1AW0880) COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) COCONUT ALKANES (UNII: 1E5KJY107T) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) ISODODECANE (UNII: A8289P68Y2) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIHYDROXYSTEARIN (UNII: 06YD7896S3) TOCOPHEROL (UNII: R0ZB2556P8) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) SQUALANE (UNII: GW89575KF9) POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR) STEARALKONIUM HECTORITE (UNII: OLX698AH5P) PROPANEDIOL (UNII: 5965N8W85T) TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q) SODIUM CHLORIDE (UNII: 451W47IQ8X) SORBIC ACID (UNII: X045WJ989B) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69423-690-44 1 in 1 CARTON 05/10/2023 1 44 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 05/01/2023 Labeler - The Procter & Gamble Manufacturing Company (004238200)