ACTIVE SPF 45- broad spectrum lotion

Active by

Drug Labeling and Warnings

Active by is a Otc medication manufactured, distributed, or labeled by CP Skin Health Group, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Octisalate 4.9%, Octocrylene 8.1%, Zinc Oxide 8%

Purpose

Sunscreen

Uses

Helps prevent sunburn

If used as directed with other sun protection measures (see Direction), 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

Stop use and ask a doctor if skin rash occurs.

When using this product keep out of eyes. Rinse with water to remove.

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.

Directions

Apply liberally 15 minutes before sun exposure

Reapply:

- after 80 minutes of swimming or sweating

- immediately after towel drying

- at least every 2 hours

Children under 6 months: 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 borad specturm SPF value of 15 or higher and other skin protecting measures including:

- limit time in the sun, specially from 10a.m. - 2 p.m.

- weare long-sleeved shirts, pants, hats, and sunglasses

Other information

Protect this product from excessive heat and direct sun.

Inactive Ingredients

Acrylamide/Sodium Acryloyldimethyltaurate Copolymer
Bisabolol
Butyloctyl Salicylate
C13-14 Alkane
Caffeine
Caprylyl Methicone
Cetearyl Alcohol
Cetearyl Olivate
Cetyl Palmitate
Ethyl Ferulate
Ethylhexyl Methoxycrylene
Ethylhexylglycerin
Isohexadecane
Neopentyl Glycol Diheptanoate
Phenoxyethanol
Polyester-7
Polysorbate 80
Propanediol
Sodium Gluconate
Sorbitan Oleate
Sorbitan Olivate
Sorbitan Palmitate
Styrene/Acrylates Copolymer
Triethoxycaprylylsilane
Water
Xanthan Gum

Questions or comments?

877.722.7546

Active

INGREDIENTS AND APPEARANCE

ACTIVE  SPF 45
broad spectrum lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68726-264
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	8.5 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	8 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PROPANEDIOL (UNII: 5965N8W85T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SORBITAN OLIVATE (UNII: MDL271E3GR)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
SORBITAN MONOPALMITATE (UNII: 77K6Z421KU)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
POLYESTER-7 (UNII: 0841698D2F)
WATER (UNII: 059QF0KO0R)
ISOHEXADECANE (UNII: 918X1OUF1E)
XANTHAN GUM (UNII: TTV12P4NEE)
CAFFEINE (UNII: 3G6A5W338E)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
LEVOMENOL (UNII: 24WE03BX2T)
SODIUM GLUCONATE (UNII: R6Q3791S76)
ETHYL FERULATE (UNII: 5B8915UELW)
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68726-264-12	85 g in 1 TUBE; Type 0: Not a Combination Product	05/01/2020
2	NDC: 68726-264-37	7.4 g in 1 TUBE; Type 0: Not a Combination Product	05/01/2020	05/31/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/01/2020

Labeler - CP Skin Health Group, Inc. (611921669)