Label: SUPERNATURAL AIRBRUSHED CANVAS BROAD SPECTRUM SPF 15 SUNSCREEN RICH- zinc oxide cream
- NDC Code(s): 50184-1029-1, 50184-1029-2
- Packager: philosophy
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active Ingredients
Zinc Oxide (5.%)Close
- Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.Close
- helps prevent sunburn
- if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
For external use only.
Do not use on damaged or broken skin.
When using this product keep out of eyes.
Rinse with water to remove.
Stop use and ask a doctor if rash occurs.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.Close
- apply liberally 15 minutes before sun exposure on clean, dry skin
- use a water resistant sunscreen if swimming or sweating
- 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 of 15 or higher and other sun protection measures, including:
- limit time in the sun, especially from 10 a.m.-2p.m.
- wear long-sleeve shirts, pants, hats and sunglasses
- children under 6 months of age: ask a doctor
- Inactive Ingredients
caprylyl glycol, silica, aluminum hydroxide, phenoxyethanol, triethoxycaprylylsilane, sodium dehydroacetate, bismuth oxychloride (ci 77163), mica, titanium dioxide (ci 77891), iron oxides (ci 77491, ci 77492, ci 77499).Close
- Other Information
- protect this product from excessive heat and direct sun
- Questions or Comments?
Call toll-free 1-800-568-3151 from 6 a.m.-5p.m. MST (Monday-Friday)Close
- INGREDIENTS AND APPEARANCE
SUPERNATURAL AIRBRUSHED CANVAS BROAD SPECTRUM SPF 15 SUNSCREEN RICH
zinc oxide cream
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50184-1029 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 882.7 mg in 9.1 g Inactive Ingredients Ingredient Name Strength CAPRYLYL GLYCOL (UNII: 00YIU5438U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) PHENOXYETHANOL (UNII: HIE492ZZ3T) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) BISMUTH OXYCHLORIDE (UNII: 4ZR792I587) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50184-1029-2 1 in 1 BOX 1 NDC:50184-1029-1 9.1 g in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/01/2013 Labeler - philosophy (948102256) Establishment Name Address ID/FEI Business Operations Mana Products Inc. 078870292 manufacture(50184-1029)