UNSEEN SUNSCREEN BODY SPF 40- avobenzone, homosalate, octisalate, octocrylene lotion

Unseen Sunscreen Body SPF 40 by

Drug Labeling and Warnings

Unseen Sunscreen Body SPF 40 by is a Otc medication manufactured, distributed, or labeled by Supergoop, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Avobenzone 3%

Homosalate 9%

Octisalate 5%

Octocrylene 10%

PURPOSE

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

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.

DOSAGE & ADMINISTRATION

• apply generously and evenly 15 minutes before sun exposure
• reapply: after 40 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 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: Ask a doctor

INACTIVE INGREDIENT

Inactive Ingredients: Isododecane, Dimethicone, Caprylyl Methicone, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Caprylic/CapricTriglyceride, Phenyl Trimethicone, Olea Europaea Olive Oil, Olea Europaea (Olive) Fruit Extract, Olea Europaea (Olive) Leaf Extract, Silica Dimethyl Silyate

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.

INDICATIONS & USAGE

Stop use and ask a doctor is rash occurs

PRINCIPAL DISPLAY PANEL

Unseen Sunscreen Body

SPF 40 PA +++

Broad Spectrum Sunscreen

Water and Sweat Resistant (40 minutes)

3.4 fl. oz. / 100 mL

INGREDIENTS AND APPEARANCE

UNSEEN SUNSCREEN BODY SPF 40 
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75936-605
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	9 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
OLEA EUROPAEA FRUIT VOLATILE OIL (UNII: 8E7358CX1J)
OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)
ISODODECANE (UNII: A8289P68Y2)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75936-605-01	100 mL in 1 TUBE; Type 0: Not a Combination Product	10/28/2022
2	NDC: 75936-605-02	30 mL in 1 TUBE; Type 0: Not a Combination Product	10/28/2022
3	NDC: 75936-605-03	10 mL in 1 PACKET; Type 0: Not a Combination Product	10/28/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	10/28/2022

Labeler - Supergoop, LLC (117061743)