SUMMER READY INNOVATIVE SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene cream cream

Summer Ready Innovative Sunscreen by

Drug Labeling and Warnings

Summer Ready Innovative Sunscreen by is a Otc medication manufactured, distributed, or labeled by Skin Innovations LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Avobenzone 3%

Homosalate 6%

Octisalate 4%

Octocrylene 7%

PURPOSE

Sunscreen

DOSAGE & ADMINISTRATION

apply liberally 15 minutes before sun exposure
reapply:
after 80 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 of age: Ask a doctor

KEEP OUT OF REACH OF CHILDREN

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

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

INACTIVE INGREDIENT

TROLAMINE​

ETHYLHEXYL METHOXYCRYLENE

ETHYLHEXYL PALMITATE

ETHYLHEXYLGLYCERIN

PANTHENOL

PHENOXYETHANOL

SORBITAN SESQUIOLEATE

STEARIC ACID

STEARYL ALCOHOL

CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE

MEDIUM-CHAIN TRIGLYCERIDES

CARBOMER INTERPOLYMER TYPE A (55000 CPS)

WATER

EDETATE DISODIUM ANHYDROUS​

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUMMER READY INNOVATIVE SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73231-1901
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	6 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	7 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PANTHENOL (UNII: WV9CM0O67Z)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
STEARIC ACID (UNII: 4ELV7Z65AP)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73231-1901-1	118 mL in 1 TUBE; Type 0: Not a Combination Product	07/19/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/19/2019

Labeler - JADA Wellness, LLC (045969028)

Registrant - JADA Wellness, LLC (045969028)