Label: REVIVE SENSITIF OIL FREE BROAD SPECTRUM SPF 15 SUNSCREEN- avobenzone and octinoxate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 58411-418-10 - Packager: RéVive Skincare
- 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 January 19, 2018
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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Uses
- 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.
- Warnings
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Directions
- For sunscreen use:
- apply liberally 15 minutes before sun exposure
- use a water resistant sunscreen if swimming or sweating
- reapply at least every 2 hours
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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 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
- For sunscreen use:
- Other information
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Inactive ingredients
water, diisopropyl sebacate, butylene glycol, cyclopentasiloxane, glyceryl stearate, stearic acid, cetyl phosphate, cetearyl alcohol, sh-oligopeptide-1, phenoxyethanol, sodium PCA, polysorbate 60, aminomethyl propanol, citrus aurantium dulcis (orange) fruit extract, allantoin, methylparaben, carbomer, bisabolol, propylparaben, tocopheryl acetate, disodium EDTA, laminaria saccharina extract, glycolipids, sodium hyaluronate.
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 60 ml Bottle Carton
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INGREDIENTS AND APPEARANCE
REVIVE SENSITIF OIL FREE BROAD SPECTRUM SPF 15 SUNSCREEN
avobenzone and octinoxate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-418 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIISOPROPYL SEBACATE (UNII: J8T3X564IH) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) STEARIC ACID (UNII: 4ELV7Z65AP) CETYL PHOSPHATE (UNII: VT07D6X67O) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) NEPIDERMIN (UNII: TZK30RF92W) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) POLYSORBATE 60 (UNII: CAL22UVI4M) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) ORANGE (UNII: 5EVU04N5QU) ALLANTOIN (UNII: 344S277G0Z) METHYLPARABEN (UNII: A2I8C7HI9T) LEVOMENOL (UNII: 24WE03BX2T) PROPYLPARABEN (UNII: Z8IX2SC1OH) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) HYALURONATE SODIUM (UNII: YSE9PPT4TH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-418-10 1 in 1 CARTON 11/10/2014 1 60 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 11/10/2014 Labeler - RéVive Skincare (193691821)
