California Mango Spf-30 Sunscreen

California Mango Spf-30 Sunscreen
SPL v3
SPL
SPL Set ID e0de0504-763d-4518-8a9c-67724077701d
Route
TOPICAL
Published
Effective Date 2023-05-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Octisalate (50 mg) Octocrylene
Inactive Ingredients
Kiwi Fruit Aloe Vera Leaf Ascorbyl Palmitate Butyloctyl Salicylate Safflower Coconut Oil Helianthus Annuus Flowering Top Hydrogenated Methyl Abietate Flax Seed Lycium Barbarum Fruit Punica Granatum Root Bark .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-05-22

Description

Avobenzone (3.0%), Octisalate (5.0%), Octocrylene (5.0%)

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone (3.0%), Octisalate (5.0%), Octocrylene (5.0%)

Uses:
  • Helps prevent sunburn.
  • Higher SPF gives more sunburn protection.
  • Retains SPF after 80 minutes of swmming or sweating.
  • If used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions
Warnings:

For external use only. 

Do Not Use
  • on damaged or broken skin.
Drug Facts

Questions?

Call toll free or 800-656-2646 562-946-4170

Directions:
  • Apply liberally 15 minutes before sun exposure and as needed.
  • Children under 6 months of age: ask a doctor.
  • Reapply:
  • After 80 minutes of swimming or sweating
  • Immediately after towel drying
  • At least every 2 hours
  • 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 suncreen 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.
Active Ingredients

Avobenzone (3.0%), Octisalate (5.0%), Octocrylene (5.0%)

Other Information:

Protect the product in this container from excessive heat and direct sun.

Package labeling:

Inactive Ingredients:

Actinidia Chinensis (Kiwi) Fruit Extract, Aloe Barbadensis Leaf (Aloe Vera) Extract, Ascorbyl Palmitate (Vitamin C), Butyloctyl Salicylate, Carthamus Tinctorius (Safflower) Oil, Cocos Nucifera (Coconut) Oil, Garcinia Mangostana (Mangosteen) Extract, Helianthus Annuus (Sunflower) Oil, Hydrogenated Methyl Abietate, Linum Usitatissimum (Linseed) Oil, Lycium Barbarum (Goji) Fruit Extract, Parfum (Fragrance), Punica Granatum (Pomegranante) Extract, SD-Alcohol 40B, Tocopheryl Acetate (Vitamin E).

When Using This Product
  • keep out of eyes. Rinse with water to remove.
Stop Use and Ask A Doctor If
  • rash or irritation develops and lasts.
Keep Out of Reach of Children.

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

If Pregnant Or Breast Feeding, 

ask a health professional before use.


Structured Label Content

Uses:
  • Helps prevent sunburn.
  • Higher SPF gives more sunburn protection.
  • Retains SPF after 80 minutes of swmming or sweating.
  • If used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions
Purpose

Sunscreen

Warnings:

For external use only. 

Do Not Use (Do not use)
  • on damaged or broken skin.
Drug Facts

Questions?

Call toll free or 800-656-2646 562-946-4170

Directions:
  • Apply liberally 15 minutes before sun exposure and as needed.
  • Children under 6 months of age: ask a doctor.
  • Reapply:
  • After 80 minutes of swimming or sweating
  • Immediately after towel drying
  • At least every 2 hours
  • 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 suncreen 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.
Active Ingredients

Avobenzone (3.0%), Octisalate (5.0%), Octocrylene (5.0%)

Other Information:

Protect the product in this container from excessive heat and direct sun.

Package labeling: (Package Labeling:)

Inactive Ingredients:

Actinidia Chinensis (Kiwi) Fruit Extract, Aloe Barbadensis Leaf (Aloe Vera) Extract, Ascorbyl Palmitate (Vitamin C), Butyloctyl Salicylate, Carthamus Tinctorius (Safflower) Oil, Cocos Nucifera (Coconut) Oil, Garcinia Mangostana (Mangosteen) Extract, Helianthus Annuus (Sunflower) Oil, Hydrogenated Methyl Abietate, Linum Usitatissimum (Linseed) Oil, Lycium Barbarum (Goji) Fruit Extract, Parfum (Fragrance), Punica Granatum (Pomegranante) Extract, SD-Alcohol 40B, Tocopheryl Acetate (Vitamin E).

When Using This Product (When using this product)
  • keep out of eyes. Rinse with water to remove.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • rash or irritation develops and lasts.
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.

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

ask a health professional before use.


Advanced Ingredient Data


Raw Label Data

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