Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID d0e00d97-dbf4-46af-aeda-bdfd6f49b5ab
Route
TOPICAL
Published
Effective Date 2016-09-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (7.5 g) Titanium Dioxide (10 g)
Inactive Ingredients
Water Caprylic/capric/palmitic/stearic Triglyceride Octyldodecyl Neopentanoate C12-15 Alkyl Lactate Butylene Glycol Behenyl Benzoate Steareth-2 Steareth-21 Stearic Acid Triethylhexanoin Isostearic Acid Polyglyceryl-3 Diisostearate Cetyl Alcohol Tocopherol .alpha.-tocopherol Acetate Tetrahexyldecyl Ascorbate Albizia Julibrissin Bark Calendula Officinalis Flower Glycyrrhiza Glabra Physalis Angulata Lycium Barbarum Fruit Carthamus Tinctorius Flower Oil Tremella Fuciformis Whole Hydrogenated Soybean Lecithin Panthenol Squalane Glycerin Ceramide Ng Peg-10 .beta.-sitosterol Palmitoyl Hexapeptide-12 Magnesium Chloride Potassium Chloride Sodium Chloride Zinc Chloride Lysine Peg-9 Diglycidyl Ether/sodium Hyaluronate Crosspolymer N,n-dimethylacrylamide Polysorbate 80 Stearyl Alcohol Phytantriol Xanthan Gum Cellulose Acetate Pentylene Glycol Ethoxydiglycol Behenate Triethoxycaprylylsilane Tribehenin Betaine Hexylene Glycol Disodium Edta-copper Anhydrous Citric Acid Sodium Benzoate Potassium Sorbate Sodium Dehydroacetate Ethylhexylglycerin Caprylyl Glycol Phenoxyethanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2016-09-08

Description

Octinoxate 7.50% Titanium Dioxide 10%


Medication Information

Description

Octinoxate 7.50% Titanium Dioxide 10%

Use
  • 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
  • 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 docor if rash occurs
  • Keep out of reach of children. If swalled, get medical help or contact a Poison Control Center right away.
Directions
  • Apply liberally 15 minutes before sun exposure
  • Reapply at least every 2 hours
  • Use water resistant sunscreen if swimming or sweathing
  • Sun Protection Measures: Spending time in the sun decreases risk of skin cancer and early again. To decrease this risk, regulaory 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 10:00 am - 2:00 pm. Wear long sleeved shirts, pants, hats and sunglasses.
  • Children under 6 months: ask a doctor
Other Information
  • Protect this product form excessive heat and direct sun
  • Save Carton for full directions and warnings
Active Ingredients

Octinoxate 7.50%

Titanium Dioxide 10%

Inactive Ingredients

WATER (AQUA), CAPRYLIC./CAPRIC/MYRISTIC/STEARIC TRIGLYCERIDE,

OCTYLDODECYL NEOPENTANOATE, Cl2-15 ALKYL

BENZOATE, BUffiENE GLYCOL, BEHENYL ALCOHOL, STEARETH-2,

STEARETH-21, STEARIC ACID, TRIETHYLHEXANOIN, ISOSTEARIC

ACID, POLYGLYCERYL-3 DIISOSTEARATE, CETYL ALCOHOL,

TOCOPHEROL, TOCOPHERYL ACETATE, TETRAHEXYLOECYL

ASCORBATE, ALBIZIA JULIBRISSIN BARK EXTRACT, CALENDULA

OFFICINALIS FLOWER EXTRACT, GLYCYRRHIZA GLABRA ROOT

EXTRACT, PHYSALIS ANGULATA EXTRACT, ACHRAS SAPOTA

(MAMEY) EXTRACT, LYCIUM BARBARUM FRUIT EXTRACT,

CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, TREMELLA

FUCIFORMIS SPOROCARP EXTRACT, HYDROGENATED LECITH IN,

PANTHENOL, SQUALANE, GLYCERIN, CERAMIDE NG, PEG-10

PHYTOSTEROL, PALMITOYL HEXAPEPTIDE-12, PALMITOYL

HEXAPEPTIDE-14, MAGNESIUM CHLORIDE, POTASSIUM

CHLORIDE, SODIUM CHLORIDE, ZINC CHLORIDE, LYSINE,

PHYTDSTERYUISOSTEARYL/CETYUSTEARYUBEHENYL DIMER

DILINOLEATE, SODIUM HYALURONATE CROSSPOLYMER,

DIMETHYLACRYLAMIDE/ACRYLIC ACID/POLYSTYRENE ETHYL

METHACRYLATE COPOLYMER, POLYSORBATE 80, STEARYL

ALCOHOL, PHYTANTRIOL, XANTHAN GUM, SIMETHICONE,

CELLULOSE GUM, ALUMINA, PENTYLENE GLYCOL, ETHOXYDIGLYCOL,

TRIETHOXYCAPRYLYLSILANE, TRIBEHEN IN, BETAINE,

HEXYLENE GLYCOL, DISODIUM EDTA, CITRIC ACID, SODIUM

BENZOATE, POTASSIUM SORBATE, SODIUM DEHYDROACETATE,

ETHYLHEXYLGLYCERIN, CAPRYLYL GLYCOL, PHENOXYETHANOL,

FRAGRANCE (PARFUM). MAY CONTAIN C+/·l: IRON OXIDES

(Cl 77492), MICA, IRON OXIDES (Cl 77491), TITANIUM DIOXIDE

(Cl 77891), IRON OXIDES (Cl 77499).

Principal Display Panel


Structured Label Content

Use
  • 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
  • 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 docor if rash occurs
  • Keep out of reach of children. If swalled, get medical help or contact a Poison Control Center right away.
Directions
  • Apply liberally 15 minutes before sun exposure
  • Reapply at least every 2 hours
  • Use water resistant sunscreen if swimming or sweathing
  • Sun Protection Measures: Spending time in the sun decreases risk of skin cancer and early again. To decrease this risk, regulaory 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 10:00 am - 2:00 pm. Wear long sleeved shirts, pants, hats and sunglasses.
  • Children under 6 months: ask a doctor
Other Information
  • Protect this product form excessive heat and direct sun
  • Save Carton for full directions and warnings
Active Ingredients

Octinoxate 7.50%

Titanium Dioxide 10%

Inactive Ingredients

WATER (AQUA), CAPRYLIC./CAPRIC/MYRISTIC/STEARIC TRIGLYCERIDE,

OCTYLDODECYL NEOPENTANOATE, Cl2-15 ALKYL

BENZOATE, BUffiENE GLYCOL, BEHENYL ALCOHOL, STEARETH-2,

STEARETH-21, STEARIC ACID, TRIETHYLHEXANOIN, ISOSTEARIC

ACID, POLYGLYCERYL-3 DIISOSTEARATE, CETYL ALCOHOL,

TOCOPHEROL, TOCOPHERYL ACETATE, TETRAHEXYLOECYL

ASCORBATE, ALBIZIA JULIBRISSIN BARK EXTRACT, CALENDULA

OFFICINALIS FLOWER EXTRACT, GLYCYRRHIZA GLABRA ROOT

EXTRACT, PHYSALIS ANGULATA EXTRACT, ACHRAS SAPOTA

(MAMEY) EXTRACT, LYCIUM BARBARUM FRUIT EXTRACT,

CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, TREMELLA

FUCIFORMIS SPOROCARP EXTRACT, HYDROGENATED LECITH IN,

PANTHENOL, SQUALANE, GLYCERIN, CERAMIDE NG, PEG-10

PHYTOSTEROL, PALMITOYL HEXAPEPTIDE-12, PALMITOYL

HEXAPEPTIDE-14, MAGNESIUM CHLORIDE, POTASSIUM

CHLORIDE, SODIUM CHLORIDE, ZINC CHLORIDE, LYSINE,

PHYTDSTERYUISOSTEARYL/CETYUSTEARYUBEHENYL DIMER

DILINOLEATE, SODIUM HYALURONATE CROSSPOLYMER,

DIMETHYLACRYLAMIDE/ACRYLIC ACID/POLYSTYRENE ETHYL

METHACRYLATE COPOLYMER, POLYSORBATE 80, STEARYL

ALCOHOL, PHYTANTRIOL, XANTHAN GUM, SIMETHICONE,

CELLULOSE GUM, ALUMINA, PENTYLENE GLYCOL, ETHOXYDIGLYCOL,

TRIETHOXYCAPRYLYLSILANE, TRIBEHEN IN, BETAINE,

HEXYLENE GLYCOL, DISODIUM EDTA, CITRIC ACID, SODIUM

BENZOATE, POTASSIUM SORBATE, SODIUM DEHYDROACETATE,

ETHYLHEXYLGLYCERIN, CAPRYLYL GLYCOL, PHENOXYETHANOL,

FRAGRANCE (PARFUM). MAY CONTAIN C+/·l: IRON OXIDES

(Cl 77492), MICA, IRON OXIDES (Cl 77491), TITANIUM DIOXIDE

(Cl 77891), IRON OXIDES (Cl 77499).

Principal Display Panel


Advanced Ingredient Data


Raw Label Data

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