EARTHS DAUGHTER CREAMY COCONUT SPF 15 BROAD SPECTRUM SUNSCREEN LIP BALM- avobenzone, octinoxate, octisalate, octocrylene stick

Earths Daughter Creamy Coconut SPF 15 Broad Spectrum Sunscreen Lip Balm by

Drug Labeling and Warnings

Earths Daughter Creamy Coconut SPF 15 Broad Spectrum Sunscreen Lip Balm by is a Otc medication manufactured, distributed, or labeled by Earth's Daughter. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Avobenzone 3%, Octinoxate 7.5%

Octisalate 5%, Octocrylene 5%

PURPOSE

Purpose

Sunscreen

INDICATIONS & USAGE

Usehelps prevent sunburn

WARNINGS

on damaged or broken skin

Do not use on damaged or broken skin

When using this product, keep out of eyes

Stop use and ask a doctor if rash occurs

Keep out of reach of children.

DOSAGE & ADMINISTRATION

Direction

• apply liberally 15 minutes before sun exposure
• reapply at least every 2 hours
• use a water resistance sunscreen if swimming or sweating
• Sun Protection MeasuresSpending 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
• children under 6 months of age: ask a doctor

STORAGE AND HANDLING

Other informationprotect this product from excessive heat and direct sun

INACTIVE INGREDIENT

Inactive ingredients*Cera Flava (Beeswax), *Helianthus Annuus (Sunflower) Seed Oil, *Theobroma Cacao (Cocoa) Seed Butter, *Cocos Nucifera (Coconut) Oil, *Coconut Flavor, *Aloe Barbadensis (Aloe Vera) Leaf Oil, Mixed Tocopherols (Vitamin E), *Rosmarinus Officinalis (Rosemary) Leaf Extract, *Calendula Officinalis (Calendula) Flower Extract. *Organic Ingredient

QUESTIONS

Questions or comments? 1-866-326-5477

SPL UNCLASSIFIED SECTION

Earth's Daughter

SPF 15 BROAD SPECTRUM

SUNSCREEN LIP BALM

FOR SMOOTH AND HEALTHY LIPS

Creamy Coconut

Broad Spectrum SPF 15 UVA + UVB

MADE IN USA with Imported and Domestic Ingredients

www.earthsdaughter.com

Net Wt. 0.15 oz (4.25 g) Peel here for drug facts

PRINCIPAL DISPLAY PANEL

Net Wt. 0.15 oz (4.25 g)

INGREDIENTS AND APPEARANCE

EARTHS DAUGHTER CREAMY COCONUT SPF 15 BROAD SPECTRUM SUNSCREEN LIP BALM 
avobenzone, octinoxate, octisalate, octocrylene stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85034-105
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ROSEMARY (UNII: IJ67X351P9)
COCOA BUTTER (UNII: 512OYT1CRR)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TOCOPHEROL (UNII: R0ZB2556P8)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
SUNFLOWER OIL (UNII: 3W1JG795YI)
YELLOW WAX (UNII: 2ZA36H0S2V)
COCONUT OIL (UNII: Q9L0O73W7L)

Product Characteristics
Color		Score
Shape		Size
Flavor	COCONUT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85034-105-01	4.25 g in 1 TUBE; Type 0: Not a Combination Product	08/11/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	08/11/2021

Labeler - Earth's Daughter (117145184)