sun control broad spectrum spf-30

sun control broad spectrum spf-30
SPL v1
SPL
SPL Set ID 8e34a343-7253-469f-9973-076a7ae26cbc
Route
topical
Published
Effective Date 2024-04-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
homosalate (70 mg) octisalate (50 mg) zinc cation (60 mg)
Inactive Ingredients
aloe vera leaf water butyloctyl salicylate calendula officinalis flower green tea leaf medium-chain triglycerides caprylyl glycol citric acid monohydrate watermelon coconut oil carrot glycerin glyceryl laurate glyceryl monostearate glyceryl stearate citrate isododecane magnesium aluminum silicate teprenone .alpha.-tocopherol tridecyl salicylate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-04-22
Purpose

Sunscreen

Description

Homosalate 7%, Octisalate 5%, Zinc oxide 6%

Medication Information

Warnings
  • For external use only
Uses
  • Helps to 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.
Purpose

Sunscreen

Directions
  • Apply liberally 15 minutes before sun exposure and as needed.
  • Children under 6 months of age: ask a doctor.
  • Reapply at least every 2 hours
  • Use water-resistant sunscreen if swimming or sweating
  • Sun Protection Measures.Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with 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-sleeved shirts, pants, hats, and sunglasses.
Other Information
  • Protect this product from excessive heat and direct sun.
  • May stain or damage some fabrics, materials or surfaces.
Inactive Ingredients

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butyloctyl Salicylate, Calendula Officinalis Extract, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Caprylyl Glycol, Citric Acid, Citrullus Lanatus (Watermelon) Extract, Cocos Nucifera (Coconut) Oil, Daucus Carota Sativa (Carrot) Extract, Glycerin, Glyceryl Laurate, Glyceryl Stearate, Glyceryl Stearate Citrate, Glyceryl Undecylenate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isododecane, Magnesium Aluminum Silicate, Polyhydroxystearic Acid, Polysorbate-20, Punica Granatum (Pomegranate) Extract, Teprenone, Tocopherol (Vitamin E), Tridecyl Salicylate, Trimethylsiloxysilicate.

Description

Homosalate 7%, Octisalate 5%, Zinc oxide 6%

Drug Facts

• Do Not Use 

on damaged or broken skin.

Active Ingredients

Homosalate 7%,

Octisalate 5%,

Zinc oxide 6%

Package Labelling:

Questions Or Comments?

Call 216-245-8689

• When Using This Product

keep out of eyes. Rinse with water to remove.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away

• Stop Use and Ask A Doctor If 

rash or irritation develops and last.

Structured Label Content

Warnings
  • For external use only
Uses
  • Helps to 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.
Purpose

Sunscreen

Directions
  • Apply liberally 15 minutes before sun exposure and as needed.
  • Children under 6 months of age: ask a doctor.
  • Reapply at least every 2 hours
  • Use water-resistant sunscreen if swimming or sweating
  • Sun Protection Measures.Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with 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-sleeved shirts, pants, hats, and sunglasses.
Other Information (Other information)
  • Protect this product from excessive heat and direct sun.
  • May stain or damage some fabrics, materials or surfaces.
Inactive Ingredients (Inactive ingredients)

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butyloctyl Salicylate, Calendula Officinalis Extract, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Caprylyl Glycol, Citric Acid, Citrullus Lanatus (Watermelon) Extract, Cocos Nucifera (Coconut) Oil, Daucus Carota Sativa (Carrot) Extract, Glycerin, Glyceryl Laurate, Glyceryl Stearate, Glyceryl Stearate Citrate, Glyceryl Undecylenate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isododecane, Magnesium Aluminum Silicate, Polyhydroxystearic Acid, Polysorbate-20, Punica Granatum (Pomegranate) Extract, Teprenone, Tocopherol (Vitamin E), Tridecyl Salicylate, Trimethylsiloxysilicate.

Drug Facts

• Do Not Use  (• Do not use )

on damaged or broken skin.

Active Ingredients (Active ingredients)

Homosalate 7%,

Octisalate 5%,

Zinc oxide 6%

Package Labelling:

Questions Or Comments? (Questions or comments?)

Call 216-245-8689

• When Using This Product (• When using this product)

keep out of eyes. Rinse with water to remove.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away

• Stop Use and Ask A Doctor If  (• Stop use and ask a doctor if )

rash or irritation develops and last.

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:59.833636 · Updated: 2026-03-14T23:02:50.389879