Label: ORANGE VANILLA SPF30- zinc oxide stick
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Contains inactivated NDC Code(s)
NDC Code(s): 58479-074-04 - Packager: Crossing Cultures LLC dba Goddess Garden
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 April 18, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient
- Purpose
- Uses
- Warnings
- Do not use
- Stop use and ask a doctor
- When using this product
- Keep out of reach of children
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Directions
* Apply liberally 15 minutes before sun exposure.
* Reapply:
- After 80 minutes of swimming or sweating.
- Immediately after towel drying.
- At least every 2 hours.
* Children under 6 months of age: Ask a doctor.
* 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 sun, especially from 10a.m. to 2p.m.
- Wear long-sleeved shirts, pants, hats and sunglasses.
- Other Information
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Inactive Ingredients
Bisabolol*, Butyrospermum Parkii (Shea Butter)*, Caprylic/Capric Triglyceride (Coconut Oil), Citrus Aurantium Dulcis (Orange) Peel Oil, Cocos Nucifera (Coconut) Oil*, Copernicia Cerifera (Carnauba) Wax*, Euphorbia Cerifera (Candelilla) Wax, Flavor (Natural Vanilla Flavor), Jojoba Esters, Olea Europaea (Olive) Fruit Oil*, Oryzanol, Schinziophyton Rautanenii (Mongongo) Kernel Oil*, Stevia Rebaudiana Extract, Theobroma Cacao (Cocoa) Seed Butter*, Theobroma Grandiflorum (Cupuassu) Seed Butter, Tocopherol (Vitamin E)
*Certified Organic
- Questions or Comments
- Product Label
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INGREDIENTS AND APPEARANCE
ORANGE VANILLA SPF30
zinc oxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58479-074 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 5.7 g in 100 g Inactive Ingredients Ingredient Name Strength OLIVE OIL (UNII: 6UYK2W1W1E) COCOA BUTTER (UNII: 512OYT1CRR) THEOBROMA GRANDIFLORUM SEED BUTTER (UNII: I711F13FXM) STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876) CARNAUBA WAX (UNII: R12CBM0EIZ) CANDELILLA WAX (UNII: WL0328HX19) HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58) GAMMA ORYZANOL (UNII: SST9XCL51M) TOCOPHEROL (UNII: R0ZB2556P8) SHEA BUTTER (UNII: K49155WL9Y) ORANGE OIL (UNII: AKN3KSD11B) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) LEVOMENOL (UNII: 24WE03BX2T) COCONUT OIL (UNII: Q9L0O73W7L) SCHINZIOPHYTON RAUTANENII SEED OIL (UNII: 6GSJ7A6T1E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58479-074-04 4 g in 1 TUBE; Type 0: Not a Combination Product 01/01/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/01/2017 Labeler - Crossing Cultures LLC dba Goddess Garden (078444606) Registrant - Crossing Cultures LLC dba Goddess Garden (078444606)