Label: OBAGI 360 HYDRAFACTOR MOISTURIZING BROAD SPECTRUM SPF 30 SUNSCREEN- avobenzone, octinoxate, octisalate, and oxybenzone cream
- NDC Code(s): 62032-300-09, 62032-300-37
- Packager: OBAGI COSMECEUTICAL LLC
- Category: HUMAN OTC DRUG LABEL
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 September 3, 2019
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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
- 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: Ask a doctor
- Other information
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Inactive ingredients
water (aqua), C12-15 alkyl benzoate, butyloctyl salicylate, glycerin, sodium hyaluronate, eperua falcata bark extract, dextrin, polysorbate 20, hydrolyzed caesalpinia spinosa gum, caesalpinia spinosa gum, sodium hydroxide, carbomer, acrylates/C10-30 alkyl acrylate crosspolymer, caprylyl glycol, disodium EDTA, hexylene glycol, pichia/resveratrol ferment extract, sorbitan oleate, tocopheryl acetate, ubiquinone, phenoxyethanol, ethylhexylglycerin
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 75 g Tube Carton
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INGREDIENTS AND APPEARANCE
OBAGI 360 HYDRAFACTOR MOISTURIZING BROAD SPECTRUM SPF 30 SUNSCREEN
avobenzone, octinoxate, octisalate, and oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62032-300 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 10 mg in 1 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 50 mg in 1 g Inactive Ingredients Ingredient Name Strength CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO) CAPRYLIC ALCOHOL (UNII: NV1779205D) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) ICODEXTRIN (UNII: 2NX48Z0A9G) EDETATE DISODIUM (UNII: 7FLD91C86K) EPERUA FALCATA BARK (UNII: L43J05M2KO) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLYCERIN (UNII: PDC6A3C0OX) HEXYLENE GLYCOL (UNII: KEH0A3F75J) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYSORBATE 20 (UNII: 7T1F30V5YH) HYALURONATE SODIUM (UNII: YSE9PPT4TH) SODIUM HYDROXIDE (UNII: 55X04QC32I) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) UBIDECARENONE (UNII: EJ27X76M46) WATER (UNII: 059QF0KO0R) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62032-300-37 1 in 1 CARTON 01/02/2014 12/31/2019 1 75 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:62032-300-09 1 in 1 CARTON 01/01/2020 2 75 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 01/02/2014 Labeler - OBAGI COSMECEUTICAL LLC (790553353) Establishment Name Address ID/FEI Business Operations G.S Cosmeceutical 017014734 MANUFACTURE(62032-300) , LABEL(62032-300) , PACK(62032-300)