Sunscreen Broad Spectrum Spf 50 Cream

Sunscreen Broad Spectrum Spf 50 Cream
SPL v6
SPL
SPL Set ID 73620765-c7c0-4bd7-82a9-00022773c928
Route
TOPICAL
Published
Effective Date 2017-03-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (10 g) Octinoxate (7.5 g)
Inactive Ingredients
Alkyl (c12-15) Benzoate Water Octyldodecyl Neopentanoate Polysorbate 60 Cetostearyl Alcohol Glycerin Cyclomethicone 5 Glyceryl Monostearate Peg-100 Stearate Coconut Alkanes Polyhydroxystearic Acid (2300 Mw) Coco-caprylate/caprate Dimethicone Aloe Vera Leaf Pummelo Chamaemelum Nobile Flower Pueraria Montana Var. Lobata Root Green Tea Leaf Edetate Disodium Xanthan Gum Carbomer Copolymer Type A (allyl Pentaerythritol Crosslinked) Benzyl Alcohol Ethylhexylglycerin Phenoxyethanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-03-26
Description

Active Ingredients             Purpose Octinoxate  7.5% .............  Sunscreen Zinc Oxide  10% ............... Sunscreen

Medication Information

Warnings and Precautions

Warnings

  • For external use only
  • 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
Dosage and Administration



Directions

  • Apply evenly 15 minutes before sun exposure
  • Reapply at least every 2 hours or after towel drying, swimming or sweating
  • Sun protection Measures: Spending time in the sun increases risk of skin cancer and early skin aging. To decrease the risk, regularyly use a sun screen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including

  • Sun protection Measures: Spending time in the sun increases risk of skin cancer and early skin aging. To decrease the risk, regularyly use a sun screen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

  • limit time in the sun, especially from 10am-2pm

  • wear long-sleeved shirts, pants, hats, and sunglasses

  • children under 6 months of age: Askj a doctor

Description

Active Ingredients             Purpose Octinoxate  7.5% .............  Sunscreen Zinc Oxide  10% ............... Sunscreen

Section 50565-1
  • Keep out of reach of children. If swallowed, get help or contact a Poison Control Center right away.
Section 51727-6

Inactive Ingredients

Water, C12-15, Alkyl Benzoate, Octyldodecly Neopentanoate, Polysorbate 60, Cetearyl Alcohol, Glycerin, Cyclopentasiloxane, Glyceryl Stearate, PEG - 100 Stearate, Coconut Alkanes, Polyhydroxystearic Acid, Coco-Caprylate/Caprate, Dimethicone, Aloe Barbadensis Leaf Extract, Citrus Grandis Fruit Extract, Anthemis Nobilis Flower Extract, Pueraria Lobata Root Extract, Camellia Sinensis Leaf Extract, Disodium EDTA, Xanthan Gum, Acrylates/C10-30 Alkyl Acrylates Crosspolymer, Benzyl Alcohol, Ehtylhexylglycerin, Phenoxyethanol

Section 51945-4

VI Derm

SPF 50+ Cream

Sunscreen Broad Spectrum

59 ml/2 FL OZ

Section 55105-1

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.
Section 55106-9

Active Ingredients             Purpose

Octinoxate  7.5% .............  Sunscreen

Zinc Oxide  10% ............... Sunscreen

Structured Label Content

Indications and Usage (34067-9)
  • Stop use and ask a doctor if rash occurs
Dosage and Administration (34068-7)



Directions

  • Apply evenly 15 minutes before sun exposure
  • Reapply at least every 2 hours or after towel drying, swimming or sweating
  • Sun protection Measures: Spending time in the sun increases risk of skin cancer and early skin aging. To decrease the risk, regularyly use a sun screen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including

  • Sun protection Measures: Spending time in the sun increases risk of skin cancer and early skin aging. To decrease the risk, regularyly use a sun screen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

  • limit time in the sun, especially from 10am-2pm

  • wear long-sleeved shirts, pants, hats, and sunglasses

  • children under 6 months of age: Askj a doctor

Warnings and Precautions (34071-1)

Warnings

  • For external use only
  • When using this product keep out of eyes. Rinse with water to remove
Section 50565-1 (50565-1)
  • Keep out of reach of children. If swallowed, get help or contact a Poison Control Center right away.
Section 51727-6 (51727-6)

Inactive Ingredients

Water, C12-15, Alkyl Benzoate, Octyldodecly Neopentanoate, Polysorbate 60, Cetearyl Alcohol, Glycerin, Cyclopentasiloxane, Glyceryl Stearate, PEG - 100 Stearate, Coconut Alkanes, Polyhydroxystearic Acid, Coco-Caprylate/Caprate, Dimethicone, Aloe Barbadensis Leaf Extract, Citrus Grandis Fruit Extract, Anthemis Nobilis Flower Extract, Pueraria Lobata Root Extract, Camellia Sinensis Leaf Extract, Disodium EDTA, Xanthan Gum, Acrylates/C10-30 Alkyl Acrylates Crosspolymer, Benzyl Alcohol, Ehtylhexylglycerin, Phenoxyethanol

Section 51945-4 (51945-4)

VI Derm

SPF 50+ Cream

Sunscreen Broad Spectrum

59 ml/2 FL OZ

Section 55105-1 (55105-1)

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.
Section 55106-9 (55106-9)

Active Ingredients             Purpose

Octinoxate  7.5% .............  Sunscreen

Zinc Oxide  10% ............... Sunscreen

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:34.261730 · Updated: 2026-03-14T23:07:34.278056