ADVANCED FORMULA LIP MOISTURIZER SUNSCREEN SPF 25- avobenzone,octinoxate cream

United States - English - NLM (National Library of Medicine)

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Active ingredient:
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX), OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)
Available from:
Anthony Brands LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
- Helps protect against sunburn.
Authorization status:
OTC monograph not final
Authorization number:
69144-001-07

ADVANCED FORMULA LIP MOISTURIZER SUNSCREEN SPF 25-

avobenzone,octinoxate cream

Anthony Brands 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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Advanced Formula Lip Moisturizer Sunscreen SPF 25

Drug Facts

Active ingredients

Avobenzone 3.0%

Octinoxate 7.5%

Purpose

Sunscreen

Use

Helps protect against sunburn.

Warnings

Skin Cancer/Skin Aging Alert:

Spending time in the sun oncreases your risk of skin cancer and early

skin aging.

This product has been shown only to help prevent sunburn,

not

skin cancer or early skin

aging.

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.

Keep out of reach of children.

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

Directions

Apply generously 15 minutes before sun exposure.

Children under 6 years of age: Ask a doctor

Reapply at least every 2 years.

Use a water resistant sunscreen if swimming or sweating.

Other Information

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

Inactive ingredients

PETROLATUM, BEESWAX, SHEA (BUTYROSPERMUM PARKII) BUTTER, AVOCADO

(PERSEA GRATISSIMA) OIL, FLAVOR, RESVERATROL, WHITE TEA (CAMELLIA SINENSIS)

LEAF EXTRACT, GREEN TEA (CAMELLIA SINENSIS) LEAF EXTRACT, TOCOPHEROL

ACETATE, SAFFLOWER (CARTHAMUS TINCTORIUS) SEED OIL, STEVIA (STEVIA

REBAUDIANA) LEAF EXTRACT, TITANIUM DIOXIDE

Product Labeling:

ADVANCED FORMULA LIP MOISTURIZER SUNSCREEN SPF 25

Anthony Brands LLC

avobenzone,octinoxate cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 9 144-0 0 1

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

AVO BENZO NE (UNII: G6 3QQF2NOX) (AVOBENZONE - UNII:G6 3QQF2NOX)

AVOBENZONE

0 .0 3 g in 1 g

O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

OCTINOXATE

0 .0 75 g in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

PETRO LATUM (UNII: 4T6 H12BN9 U)

YELLO W WAX (UNII: 2ZA36 H0 S2V)

SHEA BUTTER (UNII: K49 155WL9 Y)

AVO CADO O IL (UNII: 6 VNO72PFC1)

RESVERATRO L (UNII: Q36 9 O8 9 26 L)

WHITE TEA (UNII: O0 M339 6 E0 9 )

GREEN TEA LEAF (UNII: W2ZU1RY8 B0 )

.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

SAFFLO WER O IL (UNII: 6 5UEH26 2IS)

STEVIA LEAF (UNII: 6 TC6 NN0 8 76 )

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 9 144-0 0 1-0 7

1 in 1 CARTON

0 9 /0 8 /20 15

1

7 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 9 /0 8 /20 15

Labeler -

Anthony Brands LLC (080923952)

Revised: 3/2019

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