Label: (RE)SETTING REFRESHING MIST SPF 40- avobenzone, homosalate, octisalate, octocrylene spray
- NDC Code(s): 75936-361-01, 75936-361-02
- 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 October 13, 2022
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
-
DOSAGE & ADMINISTRATION
- 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 your 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.
-
INACTIVE INGREDIENT
Inactive ingredients:
Alcohol Denat., Bisabolol, Brassica Camprestris/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, Rosemarinus Officinalis (Rosemary) Leaf Oil, Silica Caprylyl Silylate
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
(RE)SETTING REFRESHING MIST SPF 40
avobenzone, homosalate, octisalate, octocrylene sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75936-361 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2.9 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 9.8 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 9.5 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.9 g in 100 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) DIHEPTYL SUCCINATE (UNII: 057N7SS26Y) LEVOMENOL (UNII: 24WE03BX2T) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) ETHYL FERULATE (UNII: 5B8915UELW) LAUROYL LYSINE (UNII: 113171Q70B) DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248) SPEARMINT OIL (UNII: C3M81465G5) ROSEMARY OIL (UNII: 8LGU7VM393) NYLON-12 (UNII: 446U8J075B) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) PEPPERMINT OIL (UNII: AV092KU4JH) CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) ISODODECANE (UNII: A8289P68Y2) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75936-361-01 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/05/2022 2 NDC:75936-361-02 100 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/05/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 01/05/2022 Labeler - Supergoop, LLC (117061743) Establishment Name Address ID/FEI Business Operations Bell International Laboratories, Inc 967781555 manufacture(75936-361)
