Label: UNSEEN SUNSCREEN BODY SPF 40- avobenzone, homosalate, octisalate, octocrylene lotion
- NDC Code(s): 75936-605-01, 75936-605-02, 75936-605-03
- 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 28, 2022
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- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
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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 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
- INACTIVE INGREDIENT
- WARNINGS
- INDICATIONS & USAGE
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
UNSEEN SUNSCREEN BODY SPF 40
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75936-605 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 9 g in 100 mL Inactive Ingredients Ingredient Name Strength DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) OLEA EUROPAEA FRUIT VOLATILE OIL (UNII: 8E7358CX1J) OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT) ISODODECANE (UNII: A8289P68Y2) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) OLEA EUROPAEA LEAF (UNII: MJ95C3OH47) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75936-605-01 100 mL in 1 TUBE; Type 0: Not a Combination Product 10/28/2022 2 NDC:75936-605-02 30 mL in 1 TUBE; Type 0: Not a Combination Product 10/28/2022 3 NDC:75936-605-03 10 mL in 1 PACKET; Type 0: Not a Combination Product 10/28/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 10/28/2022 Labeler - Supergoop, LLC (117061743)
