CALIFORNIA MANGO SPF-30 SUNSCREEN- avobenzone, octisalate, octocrylene liquid

CALIFORNIA MANGO SPF-30 SUNSCREEN by

Drug Labeling and Warnings

CALIFORNIA MANGO SPF-30 SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by CALMANGO, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Avobenzone (3.0%), Octisalate (5.0%), Octocrylene (5.0%)

Purpose

Sunscreen

Uses:

• Helps prevent sunburn.
• Higher SPF gives more sunburn protection.
• Retains SPF after 80 minutes of swmming or sweating.
• If used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions

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 or irritation develops and lasts.

Keep out of reach of children.

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

If pregnant or breast-feeding, 

ask a health professional before use.

Directions:

• Apply liberally 15 minutes before sun exposure and as needed.
• Children under 6 months of age: ask a doctor.
• 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 the risk, regularly use a suncreen with broad spectrum SPF 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.

Other Information:

Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients:

Actinidia Chinensis (Kiwi) Fruit Extract, Aloe Barbadensis Leaf (Aloe Vera) Extract, Ascorbyl Palmitate (Vitamin C), Butyloctyl Salicylate, Carthamus Tinctorius (Safflower) Oil, Cocos Nucifera (Coconut) Oil, Garcinia Mangostana (Mangosteen) Extract, Helianthus Annuus (Sunflower) Oil, Hydrogenated Methyl Abietate, Linum Usitatissimum (Linseed) Oil, Lycium Barbarum (Goji) Fruit Extract, Parfum (Fragrance), Punica Granatum (Pomegranante) Extract, SD-Alcohol 40B, Tocopheryl Acetate (Vitamin E).

Questions?

Call toll free or 800-656-2646562-946-4170

Package Labeling:

INGREDIENTS AND APPEARANCE

CALIFORNIA MANGO SPF-30 SUNSCREEN 
avobenzone, octisalate, octocrylene liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83453-405
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
KIWI FRUIT (UNII: 71ES77LGJC)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
SAFFLOWER (UNII: 4VBL71TY4Y)
COCONUT OIL (UNII: Q9L0O73W7L)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
HYDROGENATED METHYL ABIETATE (UNII: A23O709X8O)
FLAX SEED (UNII: 4110YT348C)
LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)
PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83453-405-00	177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	05/22/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/22/2023

Labeler - CALMANGO, INC (193808441)