Label: DEFENSE REFRESH SETTING MIST BROAD SPECTRUM SUNSCREEN SPF 50 SUPERGOOP- avobenzone, homosalate, octinoxate, octisalate liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 75936-134-01, 75936-134-02, 75936-134-03 - Packager: Taylor James, LTD
- Category: HUMAN OTC DRUG LABEL
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 October 21, 2021
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
Directions
Apply generously and evenly15 minutes before sun exposure
Reapply:
- after 40 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
Sun Protection Measures: Spending time in the sun increases your risk of early skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF calue of 15 or higher and other sun protection measures including:
- Limit time in the sun, especially from 10 a.m.-2p.m.
- Wear long-sleeved shirts, pants, hats, and sunglasses
Reapply at least every 2 hours
- Children under 6 months: Ask a doctor
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INACTIVE INGREDIENT
Inactive Ingredients Alcohol Denat., Bisabolol, Brassica Compestris/Aleurites Fordi Oil Copolymer, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Capryloyl Glycerin/Sebacic Acid Copolymer, Dicaprylyl Carbonate, Diethylhexyl syringlidenemalonate, Diheptyl Succinate, Ethyl Ferulate, Isododecane, Lauroyl Lysine, Mentha Piperita (Peppermint) Stem/leaf Oil, Mentha Viridis (Spearmint) Leaf Oil, Nylon-12, PVP, Rosmarinus Officinalis (Rosemary) Leaf Oil, Silica Silylate
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DEFENSE REFRESH SETTING MIST BROAD SPECTRUM SUNSCREEN SPF 50 SUPERGOOP
avobenzone, homosalate, octinoxate, octisalate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75936-134 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2.8 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 9.8 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.9 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 9.5 g in 100 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) ISODODECANE (UNII: A8289P68Y2) PEPPERMINT OIL (UNII: AV092KU4JH) SPEARMINT OIL (UNII: C3M81465G5) ROSEMARY OIL (UNII: 8LGU7VM393) LEVOMENOL (UNII: 24WE03BX2T) CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T) DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248) DIHEPTYL SUCCINATE (UNII: 057N7SS26Y) ETHYL FERULATE (UNII: 5B8915UELW) LAUROYL LYSINE (UNII: 113171Q70B) NYLON-12 (UNII: 446U8J075B) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75936-134-01 15 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 01/01/2020 2 NDC:75936-134-02 30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 01/01/2020 10/01/2021 3 NDC:75936-134-03 100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 01/01/2020 07/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 01/01/2020 Labeler - Taylor James, LTD (033381850)
