Label: SUNNYSCREEN SPF 50 STICK- zinc oxide stick
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Contains inactivated NDC Code(s)
NDC Code(s): 75936-251-02 - 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 31, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
Directions
• Apply generously and evenly 15 minutes before sun exposure and at least
every 2 hours.• 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.
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INACTIVE INGREDIENT
Inactive Ingredients Beeswax, Bertholletia Excelsa Seed Oil, Bisabolol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea Butter), Euphorbia Cerifera (Candelilla) Wax, Heptyl Undecylenate, Linum Usitassimum (Lineseed) Oil, Olea Europaea (Olive) Fruit Extract, Olea Europaea (Olive) Fruit Oil, Oryzanol, Salvia hispanica (Chia) Seed Oil, SImmondsia Chinensis (Jojoba) Seed Oil, Theobroma Cacao(Cocoa) Seed Butter, Tocopherol, Triethyl Citrate, Vanilla Planifolia Fruit Extract
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SUNNYSCREEN SPF 50 STICK
zinc oxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75936-251 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 21 g in 100 g Inactive Ingredients Ingredient Name Strength OLIVE OIL (UNII: 6UYK2W1W1E) JOJOBA OIL (UNII: 724GKU717M) COCOA BUTTER (UNII: 512OYT1CRR) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) CHIA SEED OIL (UNII: MC2LH51BO7) YELLOW WAX (UNII: 2ZA36H0S2V) SHEA BUTTER (UNII: K49155WL9Y) ORYZANOL (UNII: SST9XCL51M) HEPTYL UNDECYLENATE (UNII: W77QUB6GXO) LEVOMENOL (UNII: 24WE03BX2T) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) CANDELILLA WAX (UNII: WL0328HX19) VANILLA (UNII: Q74T35078H) LINSEED OIL (UNII: 84XB4DV00W) BRAZIL NUT OIL (UNII: 0G89T29HO6) TOCOPHEROL (UNII: R0ZB2556P8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75936-251-02 19.8 g in 1 TUBE; Type 0: Not a Combination Product 04/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 04/01/2019 Labeler - Supergoop, LLC (117061743)
