Sunforgettable® Face Primer SPF 30 Sunscreen

Drug Labeling and Warnings

Drug Details [pdf]

SUNFORGETTABLE FACE PRIMER SPF 30 SUNSCREEN- titanium dioxide and zinc oxide liquid 
Colorescience

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.

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Sunforgettable® Face Primer SPF 30 Sunscreen

Drug Facts

Active ingredients	Purpose
Titanium Dioxide 5.4%	Sunscreen
Zinc Oxide 5.4%	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

• Apply liberally 15 minutes before sun exposure. Works best on moisturized skin.
• Reapply:
  • After 40 minutes of swimming or sweating.
  • Immediately after towel drying.
  • At least every 2 hours.
• 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.

Inactive ingredients

Cyclopentasiloxane, Caprylic/Capric Triglyceride, Dimethicone Crosspolymer, Glycerin, Water/Aqua/Eau, Dimethicone/Vinyl Dimethicone Crosspolymer, Spirulina Maxima Extract, Camellia Sinensis Leaf Extract, Opuntia Ficus-Indica Stem Extract, Palmaria Palmata Extract, Disodium Lauriminodipropionate Tocopheryl Phosphates, Citrus Paradisi (Grapefruit) Seed Extract, Ascorbic Acid, Dimethiconol, Vanilla Planifolia Fruit Extract, Fusanus Spicatus Wood Oil, Butylene Glycol, Dimethicone, Triethoxycaprylylsilane, Cyclotetrasiloxane, BHT, Propyl Gallate, Tyrosine, Glucose, Benzoic Acid, Dehydroacetic Acid, Phenoxyethanol, Beta-Carotene (CI 40800), Iron Oxides (CI 77491, CI 77492, CI 77499)

Other information

• Protect this product from excessive heat and direct sun.

Questions or comments?

Call toll free 866.426.5673

Manufactured by Colorescience®
Carlsbad, CA 92008

PRINCIPAL DISPLAY PANEL - 30 ml Tube Carton

colorescience®

face primer

SPF 30
sunforgettable®

Broad Spectrum SPF 30
sunscreen

1 fl oz / 30 ml

SUNFORGETTABLE FACE PRIMER SPF 30 SUNSCREEN 
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68078-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	54 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	54 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Cyclomethicone 5 (UNII: 0THT5PCI0R)
BETA CAROTENE (UNII: 01YAE03M7J)
Dimethicone/Vinyl Dimethicone Crosspolymer (Soft Particle) (UNII: 9E4CO0W6C5)
Cyclomethicone 4 (UNII: CZ227117JE)
Water (UNII: 059QF0KO0R)
Vanilla (UNII: Q74T35078H)
Opuntia Ficus-Indica (UNII: 23Z87HTQ6P)
Glycerin (UNII: PDC6A3C0OX)
Dimethicone (UNII: 92RU3N3Y1O)
Disodium Lauriminodipropionate Tocopheryl Phosphates (UNII: 0K5Y9U1P6M)
Butylene Glycol (UNII: 3XUS85K0RA)
Triethoxycaprylylsilane (UNII: LDC331P08E)
Benzoic Acid (UNII: 8SKN0B0MIM)
ARTHROSPIRA MAXIMA (UNII: 9K7IG15M0Q)
Dehydroacetic Acid (UNII: 2KAG279R6R)
Phenoxyethanol (UNII: HIE492ZZ3T)
Dulse (UNII: 7832HOY4ZQ)
Green Tea Leaf (UNII: W2ZU1RY8B0)
Propyl Gallate (UNII: 8D4SNN7V92)
Tyrosine (UNII: 42HK56048U)
Dextrose, Unspecified Form (UNII: IY9XDZ35W2)
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)
Citrus Paradisi Seed (UNII: 12F08874Y7)
Ascorbic Acid (UNII: PQ6CK8PD0R)
Medium-Chain Triglycerides (UNII: C9H2L21V7U)
Santalum Spicatum Oil (UNII: H9LVS6REV4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68078-010-11	1 in 1 CARTON	10/05/2015	06/11/2017
1		30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	10/05/2015	06/11/2017

Labeler - Colorescience (128731929)

Revised: 7/2019

Document Id: b26e8608-21e6-4312-9fdb-4593f18f90e5

34390-5

Set id: b40f6e83-0b88-406b-880d-ba475a588ff1

Version: 2

Effective Time: 20190701