Label: LIP ORANGE VANILLA SPF30- zinc oxide stick
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Contains inactivated NDC Code(s)
NDC Code(s): 58479-639-04 - 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 May 8, 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)*, Calophyllum Inophyllum (Tamanu) Oil*, Capric/Caprylic Triglyceride (Fractionated Coconut Oil), Citrus Aurantium Dulcis (Orange) Peel Oil*, Cocos Nucifera (Coconut) Oil*, Copernicia Cerifera (Carnauba) Wax*, Euphorbia Cerifera (Candelilla) Wax, Natural Flavor*, Olea Europaea (Olive) Oil*, Pongamia Glabra (Karanja) Seed Oil*, Schinziophyton Rautanenii (Mongongo) Kernel Oil*, Stearic Acid, Stevia Rebaudiana Leaf/Stem Extract, Theobroma Cacao (Cocoa) Seed Butter*, Theobroma Grandiflorum (Cupuacu) Butter*, Tocopherol
*Organic
- Questions or Comments
- Product Label
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INGREDIENTS AND APPEARANCE
LIP ORANGE VANILLA SPF30
zinc oxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58479-639 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 8.55 g in 100 g Inactive Ingredients Ingredient Name Strength SHEA BUTTER (UNII: K49155WL9Y) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) LEVOMENOL (UNII: 24WE03BX2T) COCONUT OIL (UNII: Q9L0O73W7L) CARNAUBA WAX (UNII: R12CBM0EIZ) OLIVE OIL (UNII: 6UYK2W1W1E) SCHINZIOPHYTON RAUTANENII SEED OIL (UNII: 6GSJ7A6T1E) STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876) THEOBROMA GRANDIFLORUM SEED BUTTER (UNII: I711F13FXM) STEARIC ACID (UNII: 4ELV7Z65AP) ORANGE OIL (UNII: AKN3KSD11B) CANDELILLA WAX (UNII: WL0328HX19) COCOA BUTTER (UNII: 512OYT1CRR) TOCOPHEROL (UNII: R0ZB2556P8) TAMANU OIL (UNII: JT3LVK84A1) KARUM SEED OIL (UNII: 62160PU6FJ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58479-639-04 4 g in 1 TUBE; Type 0: Not a Combination Product 02/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 02/01/2018 Labeler - Crossing Cultures LLC dba Goddess Garden (078444606) Registrant - Crossing Cultures LLC dba Goddess Garden (078444606)