Label: UMBRELLA- octinoxate titanium dioxide lotion
- NDC Code(s): 35192-007-01
- Packager: CA-BOTANA INTERNATIONAL
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 12, 2023
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- Official Label (Printer Friendly)
- Warning and Precautions Section
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DOSAGE & ADMINISTRATION SECTION
Helps prevent sunburn. If used as directed with other sun protection measured decreases the risk of skin cancer and early skin aging caused by the sun. Apply liberally 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply: at least 2 hours. Children under 6 months: Ask a doctor. Sun protection measurements. 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 - 2 p.m. Wear long-sleeve shirts, pants, hats, and sunglasses. Protect this product from excessive heat and direct sun
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INACTIVE INGREDIENT SECTION
ALOE VERA LEAF
ALUMINUM STARCH OCTENYLSUCCINATE
ASCORBIC ACID
ASCORBYL PALMITATE
BORON NITRIDE
CAMELLIA SINENSIS FLOWER
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES
STEARYL ALCOHOL
CETYL ALCOHOL
CETEARYL ESONONANOATE
CITRIC ACID MONOHYDRATE
CITRUS AURANTIUM FLOWER OIL
COCO-CAPRYLATE
ETHYLHEXYLGLYCERIN
GLYCERIN
SUNFLOWER OIL
NEACEN
PANTHENOL
PHENOXYETHANOL
EGG PHOSPHOLIPIDS
POTASSIUM SORBATE
PROPANEDIOL
ROSMARINUS OFFICINALIS FLOWERING TOP OIL
PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER
SORBITAN STEARATE
TOCOPHEROL
GRAPE SEED OIL
XANTHAN GUM
WATER
- OTC - ACTIVE INGREDIENT SECTION
- OTC - PURPOSE SECTION
- keep out of reach of children section
- WARNINGS
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INDICATIONS & USAGE
Helps prevent sunburn. If used as directed with other sun protection measured decreases the risk of skin cancer and early skin aging caused by the sun. Apply liberally 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply: at least 2 hours. Children under 6 months: Ask a doctor. Sun protection measurements. 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 - 2 p.m. Wear long-sleeve shirts, pants, hats, and sunglasses. Protect this product from excessive heat and direct sun
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
UMBRELLA
octinoxate titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:35192-007 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.268 g in 56.7 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.268 g in 56.7 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) ASCORBIC ACID (UNII: PQ6CK8PD0R) ASCORBYL PALMITATE (UNII: QN83US2B0N) BORON NITRIDE (UNII: 2U4T60A6YD) CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17) CAPRYLIC/CAPRIC MONO/DIGLYCERIDES (UNII: U72Q2I8C85) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) CETYL ALCOHOL (UNII: 936JST6JCN) CETEARYL ISONONANOATE (UNII: P5O01U99NI) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) CITRUS AURANTIUM FLOWER OIL (UNII: D4BGE91OXH) COCO-CAPRYLATE (UNII: 4828G836N6) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLYCERIN (UNII: PDC6A3C0OX) SUNFLOWER OIL (UNII: 3W1JG795YI) NIACIN (UNII: 2679MF687A) PANTHENOL (UNII: WV9CM0O67Z) PHENOXYETHANOL (UNII: HIE492ZZ3T) EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) PROPANEDIOL (UNII: 5965N8W85T) ROSMARINUS OFFICINALIS FLOWERING TOP OIL (UNII: OXN0D3N28L) PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER (UNII: 788QAG3W8A) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) TOCOPHEROL (UNII: R0ZB2556P8) GRAPE SEED OIL (UNII: 930MLC8XGG) XANTHAN GUM (UNII: TTV12P4NEE) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:35192-007-01 56.7 g in 1 TUBE; Type 0: Not a Combination Product 08/01/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 08/01/2013 Labeler - CA-BOTANA INTERNATIONAL (106276728) Registrant - RODOLFO UGELSTAD (106276728) Establishment Name Address ID/FEI Business Operations CA-BOTANA INTERNATIONAL 106276728 manufacture(35192-007)
