Raw Elements Baby+kids Broad Spectrum Spf30 Lotion

Raw Elements Baby+kids Broad Spectrum Spf30 Lotion
SPL v2
SPL
SPL Set ID fda8fce8-a164-45b5-b6ca-b1efce474089
Route
TOPICAL
Published
Effective Date 2019-06-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (250 mg)
Inactive Ingredients
Sunflower Oil Yellow Wax Calendula Officinalis Flower Rosemary Tocopherol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-04-15

Description

Non-Nano Zinc Oxide 25%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Non-Nano Zinc Oxide 25%

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
Warnings

For external use only.

Directions
  • apply liberally 15 minutes before sun exposure, 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 this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 am-2 pm
  • wear long-sleeve shirts, pants, hats, and sunglasses
  • children under 6 months: Ask a doctor
Do Not Use

on damaged or broken skin.

Other Information
  • protect this product from excessive heat and direct sun
Package Labeling:

Active Ingredients

Non-Nano Zinc Oxide 25%

Inactive Ingredients

Helianthus Annuus (Organic Sunflower) Seed Oil, Cera Alba (Organic Beeswax), Cocos Nucifera (Organic Coconut) Oil, Theobroma Cacao (Organic Cocoa) Seed Butter, Calendula Officinalis (Organic Calendula) Flower Extract, Organic Chamomilla Recutita (Organic Chamomile) Flower Extract, Rosmarinus Officinalis (Natural Rosemary) Leaf Extract, Tocopherol (Natural Sunflower Vitamin E)

Questions Or Comments?

Call toll free 1-888-442-6676

When Using This Product

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor

if rash occurs.

Keep Out of Reach of Children.

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


Structured Label Content

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
Purpose

Sunscreen

Warnings

For external use only.

Directions
  • apply liberally 15 minutes before sun exposure, 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 this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 am-2 pm
  • wear long-sleeve shirts, pants, hats, and sunglasses
  • children under 6 months: Ask a doctor
Do Not Use (Do not use)

on damaged or broken skin.

Other Information (Other information)
  • protect this product from excessive heat and direct sun
Package Labeling:

Active Ingredients

Non-Nano Zinc Oxide 25%

Inactive Ingredients (Inactive ingredients)

Helianthus Annuus (Organic Sunflower) Seed Oil, Cera Alba (Organic Beeswax), Cocos Nucifera (Organic Coconut) Oil, Theobroma Cacao (Organic Cocoa) Seed Butter, Calendula Officinalis (Organic Calendula) Flower Extract, Organic Chamomilla Recutita (Organic Chamomile) Flower Extract, Rosmarinus Officinalis (Natural Rosemary) Leaf Extract, Tocopherol (Natural Sunflower Vitamin E)

Questions Or Comments? (Questions or comments?)

Call toll free 1-888-442-6676

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

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

if rash occurs.

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

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


Advanced Ingredient Data


Raw Label Data

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