Sunscreen Facestick SPF30: Package Insert and Label Information

SUNSCREEN FACESTICK SPF30- zinc oxide lotion
Llama Cosmetics LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

This product is manufactured with the ingredients as listed.

Zinc Oxide 22%wt

Purpose

Sunscreen

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.

Warnings

-When using this product keep out of eyes. Rinse with water to remove.

Do not use

-in children less than 6 months of age

-on open skin wounds

Use as directed

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

Directions

Directions

-Apply generously and evenly 15 minutes before sun exposure

-Children under 6 months of age: Ask a doctor

-For sunscreen use apply to all skin exposed to the sun

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 value 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

-reapply after 80 minutes swimming or sweating

-immediately after towel drying

-at least every 2 hours

Other information

-Store at room temperature, avoid large variations in temperature.

-Keep in dry conditions and avoid contact with moisture.

Inactive ingredients

Chlorella, Raw Cacao, Iron Oxide, Beeswax, Coconut Oil, Shea Butter, Vitamin E, Carrot Powder

Albedo SPF 30 FaceStick Sunscreen

SPF 30, Water Resistant 80min, Sunscreen Facestick Packaging

SPF30 Facestick Image
(click image for full-size original)
SUNSCREEN FACESTICK SPF30
facestick sunscreen lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:81055-000
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 22 mg in 100 mg
Inactive Ingredients
Ingredient Name Strength
PEG-8 BEESWAX 33 mg in 100 mg
Product Characteristics
Color Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:81055-000-00 41 mg in 1 NOT APPLICABLE None
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 10/01/2020
Labeler — Llama Cosmetics LLC (033307798)
Establishment
Name Address ID/FEI Operations
Llama Cosmetics LLC 033307798 manufacture (81055-000)

Revised: 11/2020 Llama Cosmetics LLC

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