Label: SUNNYSCREEN SPF 50- titanium dioxide, zinc oxide lotion
- NDC Code(s): 75936-250-01, 75936-250-02
- Packager: Supergoop, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 14, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
-
DOSAGE & ADMINISTRATION
Directions
- Apply liberally and generously 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
Avena Sativa (Oat) Kernel Flour, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, C9-12 Alkane, Caesalpinia Spinosa Gum, Calendula Officinalis Flower Extract, Caprylhydroxamic Acid, Caprylic/Capric Triglyceride,Cetearyl Alcohol,Chamomila Recutita (Matricaria) Flower Extract, Coco-Caprylate/Caprate, Ethylhexylglycerin, Glycerin, Glyceryl Caprylate, Glyceryl Stearate, Haematococcus Pluvialis Extract, Helianthus Annuus (Sunflower) Seed Oil, Hydrolyzed Jojoba Esters, Jojoba Esters, Methyl Dihydroabietate, Myrciaria Dubia Fruit Extract, Polyhydroxystearic Acid, Propanediol, Sea Water, Silica, Sodium Phytate, Sorbitan Stearate, Sorbityl Laurate, Stearic Acid, Water
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
SUNNYSCREEN SPF 50
titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75936-250 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 3.4 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 23.8 g in 100 mL Inactive Ingredients Ingredient Name Strength METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F) MYRCIARIA DUBIA FRUIT (UNII: YSW4EM1EKP) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) PHYTATE SODIUM (UNII: 88496G1ERL) SORBITYL LAURATE (UNII: 23XPH3M9LR) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) SHEA BUTTER (UNII: K49155WL9Y) HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W) PROPANEDIOL (UNII: 5965N8W85T) SODIUM CHLORIDE (UNII: 451W47IQ8X) GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) WATER (UNII: 059QF0KO0R) OATMEAL (UNII: 8PI54V663Y) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) CHAMOMILE (UNII: FGL3685T2X) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLYCERIN (UNII: PDC6A3C0OX) HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472) SUNFLOWER OIL (UNII: 3W1JG795YI) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75936-250-01 89 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/01/2019 2 NDC:75936-250-02 5 mL in 1 PACKET; Type 0: Not a Combination Product 04/01/2019 05/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 04/01/2019 Labeler - Supergoop, LLC (117061743)
