dd cream spf 30

dd cream spf 30
SPL v2
SPL
SPL Set ID ea90bb4d-6f4a-45c9-e053-2a95a90a53a7
Route
topical
Published
Effective Date 2016-12-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
titanium dioxide (3.3 g) zinc oxide (12.05 g)
Inactive Ingredients
water dextrin palmitate (corn; 20000 mw) 2,3-dimethylacrylic acid, (e)- ethoxydiglycol behenate hexylene glycol lysine nordihydroguaiaretic acid, (+/-)- octyldodecyl neopentanoate palmitoyl hexapeptide-12 phenoxyethanol egg phospholipids polyglyceryl-3 distearate polysorbate 80 potassium chloride silicon sodium chloride squalane stearic acid superoxide dismutase (cu-zn) saccharomyces cerevisiae tetrahexyldecyl ascorbate triethylhexanoin xanthan gum behenyl behenate caprylic/capric/palmitic/stearic triglyceride .alpha.-cellulose disodium edta-copper butylene glycol lycium barbarum fruit magnesium chloride oleanolic acid panthenol peg-60 almond glycerides phytantriol dimethicone sodium benzoate sodium dehydroacetate hydrogenated soybean lecithin isostearic acid steareth-2 steareth-21 tocopherol triethoxycaprylylsilane aluminum aluminum hydroxide c12-15 alcohols caprylyl glycol carbomer 940 cetyl alcohol

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug active Since 2016-12-12

Description

Titanium Dioxide 3.30% Zinc Oxide 12.05%


Medication Information

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.
Indications and Usage

Stop use and ask a doctor if rash occurs.

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
Inactive Ingredients

Alumina, Aluminum Hydroxide, Behenyl Alcohol, Butylene Glycol, C12-15 Alkyl Benzoate, Caprylic/Capric/Myristic/Stearic Triglyceride, Caprylyl Glycol, Carbomer, Cellulose Gum, Cety Alcohol, Dextrin Palmitate, Dimethicone, Dimethylacrylamide/Acrylic Acid/Plystyrene Ethyl Methacylate, Disodium EDTA, Ethoxydiglycol, Ethylhexylglycerin, Glycerin, Hexylene Glycol, Hydrogenated Lecithin, Isostearic Acid, Lycium Barbarum Fruit Extract, Lysine, Magnesium Chloride, Nordihydroguaiaretic Acid, Octyldodecyl Neopenanoate, Oleanolic Acid, Palmitoyl Hexapeptide-14, Panthenol, PEG-60 Almond Glycerides, Phenoxyethanol, Phospholipids, Phytantriol, Polygleceryl-3 Diisostearate, Polysorbate 80, Potassium Chloride, Silica, Sodium Benozate, Sodium Chloride, Sodium Dehydroacetate, Sodium Hyaluronate Crosspolymer, Sodium Hydroxide, Squalane, Steareth-2, Steareth-21, Stearic Acid, Superoxide Dismutase, Tetrahexyldecyl Ascorbate, Tocopherol, Tocopheryl Acetate, Triethoxycaprylylsilane, Triethylhexanoin, Water, Xanthan Gum, Zinc Chloride May Contain (+/-): Mica, Iron Oxides.

Description

Titanium Dioxide 3.30% Zinc Oxide 12.05%

Principal Display Panel

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.
Section 43683-2

Dosage & Admin update

Section 50565-1

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Active Ingredients

Titanium Dioxide 3.30%

Zinc Oxide 12.05%


Structured Label Content

Warnings (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.
Indications and Usage (34067-9)

Stop use and ask a doctor if rash occurs.

Directions (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 (OTHER INFORMATION)

  • Protect this product form excessive heat and direct sun
Inactive Ingredients (INACTIVE INGREDIENTS)

Alumina, Aluminum Hydroxide, Behenyl Alcohol, Butylene Glycol, C12-15 Alkyl Benzoate, Caprylic/Capric/Myristic/Stearic Triglyceride, Caprylyl Glycol, Carbomer, Cellulose Gum, Cety Alcohol, Dextrin Palmitate, Dimethicone, Dimethylacrylamide/Acrylic Acid/Plystyrene Ethyl Methacylate, Disodium EDTA, Ethoxydiglycol, Ethylhexylglycerin, Glycerin, Hexylene Glycol, Hydrogenated Lecithin, Isostearic Acid, Lycium Barbarum Fruit Extract, Lysine, Magnesium Chloride, Nordihydroguaiaretic Acid, Octyldodecyl Neopenanoate, Oleanolic Acid, Palmitoyl Hexapeptide-14, Panthenol, PEG-60 Almond Glycerides, Phenoxyethanol, Phospholipids, Phytantriol, Polygleceryl-3 Diisostearate, Polysorbate 80, Potassium Chloride, Silica, Sodium Benozate, Sodium Chloride, Sodium Dehydroacetate, Sodium Hyaluronate Crosspolymer, Sodium Hydroxide, Squalane, Steareth-2, Steareth-21, Stearic Acid, Superoxide Dismutase, Tetrahexyldecyl Ascorbate, Tocopherol, Tocopheryl Acetate, Triethoxycaprylylsilane, Triethylhexanoin, Water, Xanthan Gum, Zinc Chloride May Contain (+/-): Mica, Iron Oxides.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Use (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.
Section 43683-2 (43683-2)

Dosage & Admin update

Section 50565-1 (50565-1)

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Active Ingredients (ACTIVE INGREDIENTS)

Titanium Dioxide 3.30%

Zinc Oxide 12.05%


Advanced Ingredient Data


Raw Label Data

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