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NDC 69842-0178-11 CVS Health 75; 50; 145 mg/mL; mg/mL; mg/mL Details

CVS Health 75; 50; 145 mg/mL; mg/mL; mg/mL

CVS Health is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by CVS Pharmacy. The primary component is OCTINOXATE; OCTISALATE; ZINC OXIDE.

Product Information

NDC	69842-0178
Product ID	69842-178_b7a5b305-3eae-077b-e053-2a95a90a30a1
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	CVS Health
Proprietary Name Suffix	Baby SPF 50 Mineral-Based Sun
Non-Proprietary Name	Octinoxate, Octisalate, Zinc Oxide
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	75; 50; 145
Active Ingredient Units	mg/mL; mg/mL; mg/mL
Substance Name	OCTINOXATE; OCTISALATE; ZINC OXIDE
Labeler Name	CVS Pharmacy
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2024-12-31

Package

Package Images

NDC 69842-0178-11 (69842017811)

Pricing Information	N/A
NDC Package Code	69842-178-11
Billing NDC	69842017811
Package	237 mL in 1 BOTTLE (69842-178-11)
Marketing Start Date	2018-03-09
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 66fa70b8-ea9c-3bcd-e053-2991aa0acda2 Details

Active ingredients

Octinoxate 7.5%, Octisalate 5.0%, Zinc Oxide 14.5%

Purpose

Sunscreen

Uses

helps prevent sunburn
if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

SPL UNCLASSIFIED SECTION

Do not use

on damaged or broken skin.

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

Stop use and ask doctor if •rash occurs.

SPL UNCLASSIFIED SECTION

Keep out of reach of children. If 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 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-sleeve shirts, pants, hats, and sunglasses

Other information

• protect this product from excessive heat and direct sun

• may stain or damage some fabrics, materials or surfaces

Inactive ingredients

water, propylene glycol, c12-15 alkyl benzoate, neopentyl glycol diheptanoate, cyclopentasiloxane, cetyl PEG/PPG-10/1 dimethicone, PEG-12 dimethicone crosspolymer, triethoxycaprylylsilane, aloe barbadensis leaf juice, ethylhexyl palmitate, diazolidinyl urea, methylparaben, propylparaben, sodium chloride

CVS Health Baby SPF 50 Mineral Based Lotion

NDC 69842-178-22

6 fl oz (177 mL)

CVS Health Baby SPF 50 Mineral Based Lotion

NDC 69842-178-11

8.0 fl oz (237 mL)

INGREDIENTS AND APPEARANCE

CVS HEALTH BABY SPF 50 MINERAL-BASED SUN

octinoxate, octisalate, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69842-178
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	145 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
CYCLOMETHICONE 4 (UNII: CZ227117JE)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69842-178-22	177 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/09/2018
2	NDC:69842-178-11	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/09/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	03/09/2018

Labeler - CVS Pharmacy (062312574)

Revised: 12/2020

Document Id: b7a5b305-3eae-077b-e053-2a95a90a30a1

Set id: 66fa70b8-ea9c-3bcd-e053-2991aa0acda2

Version: 2

Effective Time: 20201229

Search by Drug Name or NDC

NDC 69842-0178-11 CVS Health 75; 50; 145 mg/mL; mg/mL; mg/mL Details

CVS Health 75; 50; 145 mg/mL; mg/mL; mg/mL

Product Information

Package

Package Images

NDC 69842-0178-11 (69842017811)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 66fa70b8-ea9c-3bcd-e053-2991aa0acda2 Details

Active ingredients

Purpose

Uses

Warnings

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Directions

Other information

Inactive ingredients

CVS Health Baby SPF 50 Mineral Based Lotion

INGREDIENTS AND APPEARANCE

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