MOISTURIZER- avobenzone cream 
Oxygen Development LLC

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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Laura Mercier Pure Canvas Primer Protecting Broad Spectrum Spf 30 Sunscreen

Active ingredients

Avobenzone 3.0%, Octinoxate 7.29%, Octocrylene 3.0%, Oxybenzone 2.0%

Uses

Helps prevent sunburn

If used as directed with other sun protections measures (see Directions), decreases the risk of skin cancer and early skin again caused by the sun

Warnings

For external use only

Do not use

Do not use on damage or broken skin

When using

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

Stop use

Stop use and ask a doctor if rash occurs

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

For sunscree use: apply liberally 15 minutes sun exposure. Use a water resistant sunscreen if swimming or sweating. reapply at least every 2 hours.

Sun protections measures. Spending time in the sun increases your risk of skin cancer and early skin again. To decrease this risk, regulary use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: lomit time in the sun, especially from 10 a.m - 2 p.m. wear long - sleeve shirts, pants, hats, and sunglasses. Children unther 6 months: ask a doctor.

Other information

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

61354-039-01_AW

61354-039-02_AW

MOISTURIZER 
avobenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61354-039
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE3 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE2 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.29 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 4.98 g  in 100 g
XANTHAN GUM (UNII: TTV12P4NEE) 0.2 g  in 100 g
WATER (UNII: 059QF0KO0R) 72.61 g  in 100 g
ISOHEXADECANE (UNII: 918X1OUF1E) 4.56 g  in 100 g
PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.9 g  in 100 g
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX) 0.93 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61354-039-021 in 1 CARTON01/03/2022
1NDC:61354-039-01100 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/03/2022
Labeler - Oxygen Development LLC (137098492)
Establishment
NameAddressID/FEIBusiness Operations
Oxygen Development LLC137098492manufacture(61354-039)

Revised: 1/2022
Document Id: d4b3eb40-c9d8-f356-e053-2a95a90a9a57
Set id: d4b3eb40-c9d7-f356-e053-2a95a90a9a57
Version: 1
Effective Time: 20220103
 
Oxygen Development LLC