Self Defense Mineral Sunscreen Fluid SPF 34

Self Defense Mineral Sunscreen Fluid SPF 34 by

Drug Labeling and Warnings

Self Defense Mineral Sunscreen Fluid SPF 34 by is a Otc medication manufactured, distributed, or labeled by The Honest Company, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SELF DEFENSE MINERAL SUNSCREEN FLUID SPF 34- titanium dioxide, zinc oxide lotion 
The Honest Company, Inc.

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Self Defense Mineral Sunscreen Fluid SPF 34

Drug Facts

Active ingredients

Titanium Dioxide 2%

Zinc Oxide 15.8%

Purpose Sunscreen

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.

Do not use on damaged or broken skin

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

Directions

• Shake well. Apply liberally and evenly 15 minutes before sun exposure and as needed.
• Children under 6 months of age: Ask a doctor
• 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: at least every 2 hours ♦Use a water-resistant sunscreen if swimming or sweating

Other information ♦protect the product in this container from excessive heat and direct sun.

Inactive ingredients Water (Aqua/Eau), Dicaprylyl Carbonate, Carthamus Tinctorius (Safflower) Oleosomes, Propanediol,
Coconut Alkanes, Silica, C9-12 Alkane, Polyhydroxystearic Acid, Helianthus Annuus (Sunflower) Seed Wax, Cetyl Alcohol, Ectoin,
Sea Water, Allantoin, Glycerin, Hydroxyacetophenone, 1,2-Hexanediol, Caprylyl Glycol, Stearic Acid, Coco-Caprylate/Caprate, Gluconolactone, Trisodium Ethylenediamine Disuccinate, Sodium Benzoate, Sodium Hydroxide

HONEST ®

SELF DEFENSE

MINERAL SUNSCREEN

FLUID SPF 34

UNDER COVER

Honest Sea Water™ + Zinc Oxide

+ Titanium Dioxide + Extremolyte

ALL SKIN TYPES

1.0 fl. oz. / 30 mL

JOIN US AT HONEST.COM or call

888-862-8818

©2021 Dist. by

The Honest Company, Inc.

Los Angeles, CA 90094

Made in USA from US and imported materials

SELF DEFENSE MINERAL SUNSCREEN FLUID SPF 34 
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69366-226
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2 mg  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	15.8 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)
PROPANEDIOL (UNII: 5965N8W85T)
COCONUT ALKANES (UNII: 1E5KJY107T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
ECTOINE (UNII: 7GXZ3858RY)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
DODECANE (UNII: 11A386X1QH)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CETYL ALCOHOL (UNII: 936JST6JCN)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ALLANTOIN (UNII: 344S277G0Z)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
STEARIC ACID (UNII: 4ELV7Z65AP)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
GLYCERIN (UNII: PDC6A3C0OX)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69366-226-27	1 in 1 CARTON	07/01/2021	09/30/2023
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	07/01/2021	09/30/2023

Labeler - The Honest Company, Inc. (969962757)

Revised: 12/2023

Document Id: eea41a16-8630-7075-e053-2a95a90ac76a

34390-5

Set id: c19b83e5-c218-0cb0-e053-2995a90a73fc

Version: 3

Effective Time: 20231205