Label: SUNNYSCREEN SPF 50- titanium dioxide, zinc oxide spray
- NDC Code(s): 75936-252-01
- Packager: Supergoop, LLC
- 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 27, 2022
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- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
-
DOSAGE & ADMINISTRATION
Directions
- Apply generously and evenly 15 minutes before sun exposure
- Reapply:
- after 80 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
Aqua (Deionized water), Ascorbyl Palmitate, Butyloctyl Salicylate, Calendula Officinalis Extract, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Capryl/Caprylyl Glucoside, Chamomilla Recutita (Chamomile) Extract, Cocos Nucifera (Coconut) Oil, Daucus Carota Sativa (Carrot) Extract, Glycerin, Glyceryl Caprylate, Glyceryl Stearate Citrate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower) Oil, Mangifera Indica (Mango) Butter, Polyhydroxystearic Acid, Punica Granatum (Pomegranate) Extract, Stearic Acid, Tocopherol (Vitamin E), Xanthan Gum, Zemea (Corn) Propanediol.
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
SUNNYSCREEN SPF 50
titanium dioxide, zinc oxide sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75936-252 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 10 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 12 g in 100 mL Inactive Ingredients Ingredient Name Strength MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) COCONUT OIL (UNII: Q9L0O73W7L) WATER (UNII: 059QF0KO0R) ASCORBYL PALMITATE (UNII: QN83US2B0N) GREEN TEA LEAF (UNII: W2ZU1RY8B0) GLYCERYL STEARATE CITRATE (UNII: WH8T92A065) TOCOPHEROL (UNII: R0ZB2556P8) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) STEARIC ACID (UNII: 4ELV7Z65AP) XANTHAN GUM (UNII: TTV12P4NEE) PROPANEDIOL (UNII: 5965N8W85T) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544) GLYCERIN (UNII: PDC6A3C0OX) PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75936-252-01 100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 04/02/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 04/02/2019 Labeler - Supergoop, LLC (117061743)
