Label: DEFENSE REFRESH (RE)SETTING MIST SPF 40- avobenzone, homosalate , octisalate, octocrylene liquid
- NDC Code(s): 75936-354-01
- Packager: Supergoop LLC
- 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 May 2, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
· Shake well then apply generously and evenly 15 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 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: Ask a doctor
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INACTIVE INGREDIENT
Alcohol Denat., Bisabolol, Brassica Campestris/Aleurites Fordi Oil Copolymer, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Capryloyl Glycerin/Sebacic Acid Copolymer, Dicaprylyl Carbonate, Diethylhexyl Syringylidenemalonate, Diheptyl Succinate, Diisooctyl Succinate, Ethyl Ferulate, Isododecane, Lauroyl Lysine, Mentha Piperita (Peppermint) Oil, Mentha Viridis (Spearmint) Leaf Oil, Nylon-12, PVP, Rosmarinus Officinalis (Rosemary) Leaf Oil, Silica Caprylyl Silylate
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
DEFENSE REFRESH (RE)SETTING MIST SPF 40
avobenzone, homosalate , octisalate, octocrylene liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75936-354 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 9.8 g in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2.9 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) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248) DIHEPTYL SUCCINATE (UNII: 057N7SS26Y) ETHYL FERULATE (UNII: 5B8915UELW) ISODODECANE (UNII: A8289P68Y2) PEPPERMINT OIL (UNII: AV092KU4JH) SPEARMINT OIL (UNII: C3M81465G5) ROSEMARY OIL (UNII: 8LGU7VM393) NYLON-12 (UNII: 446U8J075B) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) LEVOMENOL (UNII: 24WE03BX2T) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T) LAUROYL LYSINE (UNII: 113171Q70B) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75936-354-01 30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 01/20/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 01/20/2021 Labeler - Supergoop LLC (117061743)
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